What changed in this filing

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Item 1. Business

2026-03-06 compared with 2025-03-06 · 119 added, 99 removed, 445 unchanged (33% of the section changed)

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We were originally incorporated in Oklahoma under the name IRI Development, Inc.

in 1992, and we merged our Oklahoma corporation into the newly formed Delaware corporation in April 2014.

in 1992, and we merged our Oklahoma corporation into the newly formed Delaware corporation, IRADIMED CORPORATION, in April 2014.

MRidium® 3870 MRI Compatible IV Infusion Pump System

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Standard infusion pumps contain magnetic and electronic components which can create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system.

Our patented MRidium® MRI compatible IV infusion pump system has been designed with a non-magnetic ultrasonic motor, uniquely designed non-ferrous parts and other special features to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures.

Our patented MRidium 3870 MRI Compatible IV Infusion Pump System, introduced in 2025, has been designed with a non-magnetic ultrasonic motor, uniquely designed non-ferrous parts, touch screen user interface, and other special features to safely and predictably deliver anesthesia and other critical care IV fluids during various MRI procedures.

Our pump solution provides a seamless approach that enables accurate, safe and dependable fluid delivery before, during and after an MRI scan, which is important to critically ill patients who cannot be removed from their vital medications, and children and infants who must generally be sedated to remain immobile during an MRI scan.

Each IV infusion pump system consists of an MRidium® MRI compatible IV infusion pump, non-magnetic mobile stand, proprietary disposable IV tubing sets and many of these systems contain additional optional upgrade accessories.

The MRidium 3870 IV Infusion Pump System consists of the MRidium 3870 MRI Compatible IV Infusion Pump, a non-magnetic IV pole mounting system, a non-magnetic mobile IV pole stand, proprietary disposable IV tubing sets and other options including a Remote Display Unit.

The optional MRidium 3875 Remote Display Unit provides the clinical user with continuous visual, audible, and remote control of the MRidium 3870 MRI Infusion Pump(s) from within the MRI Control Room, allowing the user to control the Infusion Pump(s) without the need to disrupt an active MRI scan by entering the MRI System Room.

MRidium 3860+ MRI Compatible IV Infusion Pump System

Our patented MRidium 3860+ IV Infusion Pump System has been designed with a non-magnetic ultrasonic motor, uniquely designed non-ferrous parts and other special features to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures.

The MRidium 3860+ IV Infusion Pump System consists of an MRidium MRI compatible IV infusion pump, non-magnetic mobile stand, proprietary disposable IV tubing sets and many of these systems contain additional optional upgrade accessories.

New MRidium 3860+ Pump System sales will be discontinued during 2026, with continued warranty and technical support continuing through applicable contracted periods.

IRadimed 3880 MRI Compatible Patient Vital Signs Monitoring System

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With the expanding use of MRI procedures, both traditional procedures, and intraoperative and interventional procedures, safe and reliable infusion delivery and patient monitoring in an MRI environment is becoming increasingly important to hospitals and other medical providers.

Our founder, President, Chief Executive Officer, and Chairman of our Board of Directors (the “Board” or the “Board of Directors”), Roger Susi, is a pioneer in the MRI compatible medical device industry, having invented the first MRI compatible patient monitoring system in 1986 and the first non-magnetic MRI compatible IV infusion system in 2004.

We sell our products primarily to hospitals and acute care facilities, both in the United States and internationally.

We currently employ a direct sales strategy in the United States and as of December 31, 2024, our direct

sales force consisted of 27 field sales representatives, supported by 4 regional sales directors, and supplemented by 10 clinical application specialists.

We currently employ a direct sales strategy in the United States and as of December 31, 2025, our direct sales force consisted of 29 field sales representatives, supported by 4 regional sales directors, and supplemented by 10 clinical application specialists.

Internationally, we market our products into approximately 80 countries through the use of independent distributors.

As of December 31, 2024 we have sold approximately 7,832 MRI compatible IV infusion pump systems and approximately 2,679 of our 3880 MRI compatible patient vital signs monitoring systems.

We generate revenue from the sale of MRI compatible medical devices and related accessories, extended warranty agreements, services related to maintaining our products and the sale of disposable products used with our devices.

In fiscal year 2024, our revenue was $73.2 million and our income from operations was $22.0 million representing an operating profit margin of 30 percent.

As of December 31, 2025, we have sold approximately 13,098 MRI compatible IV infusion pump system channels and approximately 3,397 of our 3880 MRI compatible patient vital signs monitoring systems.

We generate revenue from the sale of these and other MRI compatible medical devices and related accessories, extended maintenance agreements, services related to maintaining our products and the sale of disposable products used with our devices.

In fiscal year 2025, our revenue was $83.8 million and our income from operations was $26.1 million representing an operating profit margin of approximately 31.2 percent.

Refer to the information contained under the caption “Financial Highlights and Outlook” regarding our outlook for fiscal year 2026.

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Accordingly, Mr.

Susi began the formal and detailed development of what subsequently has become our MRidium MRI compatible IV infusion pump system.

This first-generation MRI compatible IV infusion pump system and its associated proprietary IV tubing sets obtained FDA 510(k) clearance in March 2005 after which we began our sales and marketing efforts.

We commenced international sales through a network of distributors and in 2006;

we signed an exclusive distribution agreement with Mallinckrodt/Tyco Healthcare (now part of Medtronic plc (NYSE:

MDT)) for domestic and Canadian distribution of our products including the MRidium 3850 MRI compatible IV infusion pump system (the predecessor to our current 3860+ model).

The exclusive arrangement ended in 2010, allowing us to implement a direct marketing strategy with our own sales force in the U.S.

In 2009, we introduced our second-generation MRI compatible IV infusion pump system, the MRidium 3860+ which improved upon the previous 3850 version in several areas, including the addition of SpO2 monitoring, and remote wireless monitoring capability.

An SpO2 monitor can signal when an insufficient level of oxygen is being supplied to the body.

Our MRidium 3860+ is the only MRI compatible IV infusion pump system on the market today.

Susi began the formal and detailed development of what subsequently became our 3850 MRidium MRI compatible IV infusion pump system.

This first-generation MRI compatible IV infusion pump system and its associated proprietary IV tubing sets obtained FDA 510(k) clearance in

March 2005 after which we began our sales and marketing efforts.

The 3860+ infusion pump system was introduced in 2009.

In May 2025, we received FDA 510(k) clearance for our new MRidium 3870 IV infusion pump system and completed our first customer shipment in December 2025.

Our MRidium 3870 and 3860+ are the only MRI compatible IV infusion pump systems on the market today.

In 2014, we began developing our own MRI compatible patient vital signs monitoring system (“3880 Monitor”).

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In October 2017, we received FDA 510(k) clearance for our 3880 Monitor and immediately began our direct selling efforts in the United States.

In 2022, we introduced our ferromagnetic detection device, IRadimed FMD1 3600 with Remote Alarm Logging Unit, (“RALU”).

This is the first ferromagnetic detection device with Tru Sense TM threat qualification technology for MRI safety strategy in hospitals.

This technology predicts an approaching ferrous hazard by uniquely

sensing a threat’s speed, trajectory, and Zone IV door status reducing false alarms, all while simultaneously circumventing background magnetic field noise.

We currently compete in the MRI compatible medical device market.

In 2022, we introduced our ferromagnetic detection device (“FMD”), IRadimed FMD1 3600 with Remote Alarm Logging Unit, (“RALU”).

This is the first FMD with Tru Sense TM threat qualification technology for MRI safety strategy in hospitals.

This technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and Zone IV door status reducing false alarms, all while simultaneously circumventing background magnetic field noise.

We currently compete in the MRI compatible medical device and related services market.

Need for MRI Compatible IV Infusion Pumps and Vital Signs Monitors

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This is particularly true for children.

As such, practitioners at hospitals and other medical facilities have been increasingly developing and using MRI for new procedures.

As such, practitioners at hospitals and other medical facilities have been increasingly developing and using MRI for new diagnostic procedures and even as an aid in therapeutic procedures.

These procedures include cardiac stress testing, intraoperative MRI and neurology MRI techniques.

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Designing MRI compatible medical devices that operate safely and effectively in the MR environment requires overcoming significant technical hurdles.

Intravenous fluids and vital signs monitoring are needed during MRI procedures for many different reasons.

IV fluids and vital signs monitoring are needed during MRI procedures for many different reasons.

Infusion pumps provide sedation to patients who are not able to remain immobile during an MRI scan and to deliver a continuous flow of critical medications to seriously ill patients, including those from critical care departments.

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Additionally, the Joint Commission on Accreditation of Healthcare Organizations requires monitoring of a patient’s vital signs while under sedation.

Further, vital signs monitoring is also required when the patient’s condition prevents them from alerting clinicians when experiencing pain, respiratory problems, cardiac distress or other difficulties that may arise during an MRI scan.

Further, vital signs monitoring is also required when the

patient’s condition prevents them from alerting clinicians when experiencing pain, respiratory problems, cardiac distress or other difficulties that may arise during an MRI scan.

Standard Infusion Pumps and Other Inadequate Alternatives

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Further, there are risks in using a standard IV infusion pump that is mistakenly believed to be at a safe distance from the MR scanner.

The powerful magnetic fields may cause metal objects in the MR environment to be drawn with

great force into the bore of the MRI system, resulting in potentially deadly projectiles.

The powerful magnetic fields may cause metal objects in the MR environment to be drawn with great force into the bore of the MRI system, resulting in potentially deadly projectiles.

Moreover, an MRI scanner’s gradient magnetic field and radiofrequency (“RF”) fields can send electrical currents through cables and other conductive materials that are near the MRI system and cause the cables to heat, which may result in burns if they come into contact with the patient or facility staff.

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Additionally, based on historical sales data and customer purchasing behaviors, we believe, that with our direct U.S.

sales team, there is potential for sales of our MRI compatible IV infusion pump system within critical care departments of U.S.

sales team, there is potential for sales of our MRI compatible IV infusion

pump system within critical care departments of U.S.

hospitals (refer to the section below titled “ Expansion of Intra-Hospital Use of MRI Compatible Devices” ).

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These additional call points within the critical care areas of a hospital often result in additional sales into radiology.

Additionally, expanded use of our MRI compatible medical devices could serve as a type of transport package and allow for consistent and uninterrupted administration of IV fluids and monitoring of vital signs, allowing for easier and safer intra-hospital transport of patients to and from the MRI scanner.

Additionally, expanded use of our MRI compatible medical devices serves as a type of transport package and allow for consistent and uninterrupted administration of IV fluids and monitoring of vital signs, allowing for easier and safer intra-hospital transport of patients to and from the MRI scanner.

It is often necessary for a patient in a critical care department of the hospital who is connected to a standard vital signs monitor and a standard IV infusion pump that is delivering critical medications to be quickly moved to the MRI facility for immediate imaging.

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We believe that the largest potential market for our MRI compatible IV infusion pumps is the segment of the market that is currently using workaround solutions.

Such solutions include using conventional pumps outside the MRI

scanner room and attaching multiple extension lines of IV tubing sets through the wall or under the door into the MRI scanner room to reach the patient.

Such solutions include using conventional pumps outside the MRI scanner room and attaching multiple extension lines of IV tubing sets through the wall or under the door into the MRI scanner room to reach the patient.

This practice of makeshift setups is fraught with risks to the patient and unnecessary costs and inefficiencies.

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We believe our 3880 MRI compatible patient vital signs monitoring system creates customer value by resolving significant workflow issues through the additional utilization achievable with our MRI monitor that is not possible with other MRI monitors.

Our 3880 Monitor’s compact and lightweight design facilitates the use of multiple monitors to support a single MRI scanner as well as the transportation of patients from their critical care unit to the MRI and back, resulting in increased patient safety through uninterrupted vital signs monitoring and decreasing the amount of time critically ill patients are away from critical care units.

Our 3880 Monitor’s compact and lightweight design facilitates the use of multiple monitors to support a single MRI scanner as well as the transportation of patients from their critical care unit to the MRI and back, resulting in increased patient safety through uninterrupted vital signs monitoring and recording and decreasing the amount of time critically ill patients are away from critical care units.

Because of the transport capabilities that only our small-sized 3880 Monitor offers, we believe multiple departments within a hospital will be interested in purchasing our device.

Other MRI monitors are too large and heavy for use in patient transport scenarios are therefore typically only located in the MRI departments of hospitals.

Other MRI monitors are considered too large and heavy for use in patient transport scenarios are therefore typically only located in the MRI departments of hospitals.

Continuing to innovate with MRI compatible patient care products.

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We intend to leverage this experience and collaboration to innovate and commercialize other technologically advanced MRI compatible patient care products.

Our 2022 introduction of our Ferromagnetic Detection system (“FMD”) is an example of this expansion.

Our 2022 introduction of our FMD and the 2025 introduction of our MRidium 3870 MRI Compatible IV Infusion Pump System are examples of this innovation that promotes safety and provides growth opportunities for us.

When reasonably available, acquiring synergistic MRI patient care companies, products, or technology licenses to accelerate our product development and leverage our existing sales organization.

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Commercial Strategy

We believe that the MRI compatible IV infusion pump market continues to have growth potential and we continue to drive increased awareness, adoption and utilization of our MRI compatible products by:

We believe that the MRI compatible IV infusion pump and monitor markets continue to have growth potential and we continue to drive increased awareness, adoption and utilization of our MRI compatible products by:

Continued development of our MRI-focused U.S.

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is the continued development of the market through driving awareness and education by our direct sales force.

Since there is no current direct competitor for an MRI compatible IV infusion pump, our focus is on expanding the market through better education on the advantages to patients, clinicians and hospitals of our current and expected infusion pump solutions and the shortcomings of current workaround practices.

Since there is no current direct competitor for an MRI compatible IV infusion pump, our focus is on expanding the market through better education on the advantages to patients, clinicians and hospitals of our latest infusion pump solutions and the shortcomings of current workaround practices.

Additionally, with our 3880 Monitor, we focus on educating customers on the total workflow benefits our devices offer and how our devices increase the efficiency of MRI scanners via patient throughput.

As business progress dictates, we intend to add to our specialized, MRI product-focused direct sales team, including our supporting clinical application specialists.

We believe that we can significantly increase sales of our MRI compatible medical devices by continuing to call on critical care departments, which may help influence hospitals’ purchasing decisions.

We believe that we can increase sales of our MRI compatible medical devices by continuing to call on critical care departments, which may help influence hospitals’ purchasing decisions.

We believe that this strategy is likely expanding the number of acute care facilities using our MRI compatible products and increasing the average number of MRI compatible IV infusion pumps and monitors per MRI scanner.

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As business progress dictates, we plan to expand our staff to serve the largest potential markets outside the U.S.

to build our relationships at the local level.

by building relationships at the local level.

Supporting commercial efforts with evidence-based information

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We believe this kind of evidence-based documentation will help us provide widespread education to the clinicians that are driving clinical practice.

We also believe that documented evidence will serve to inform the quality and risk management leaders in these organizations, which in turn may help drive the overall adoption of our MRI compatible products.

We also believe that

documented evidence will serve to inform the quality and risk management leaders in these organizations, which in turn may help drive the overall adoption of our MRI compatible products.

Providing best in class customer service and user experience

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The following diagram is representation of an aerial view of a typical MRI scanner room with a typical three Tesla magnet.

The gauss-lines illustrate the distance from the magnet where various types of medical devices can safely

The gauss-lines illustrate the distance from the magnet where various types of medical devices can safely operate.

Our 3880 MRI compatible patient vital signs monitor is the only MRI monitor that can operate safely and reliably in very close proximity to the bore of the powerful magnet used to operate the MRI (area shown in red).

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All other pumps must be placed at a distance from the MRI scanner, which may include being outside of the scanner room entirely.

We currently offer three primary products for use in the scanner room:

(1) our MRidium 3860+ MRI compatible IV infusion pump system with associated disposable IV tubing sets, (2) our 3880 MRI compatible patient vital signs monitoring system with associated disposable products, and (3) our 3600 FMD1 with RALU ferromagnetic detection device.

MRidium MRI Compatible IV Infusion Pump System

We currently offer four primary products for use in the scanner room:

(1) our MRidium 3870 MRI compatible IV infusion pump system with associated disposable IV tubing sets (2) our MRidium 3860+ MRI compatible IV infusion pump system with associated disposable IV tubing sets, (3) our 3880 MRI compatible patient vital signs monitoring system with associated disposable products, and (4) our 3600 FMD1 with RALU FMD.

MRidium MRI Compatible IV Infusion Pump Systems

The patented MRidium MRI compatible IV infusion pump system is based upon a non-magnetic, ultrasonic motor and other uniquely designed non-ferrous parts to provide accurate and dependable fluid delivery to patients undergoing an MRI procedure.

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● Able to operate virtually anywhere in the MRI scanner room;

approved for use in the presence of 0.2T to 3T magnets and fully operational up to the 10,000 gauss-line.

approved for use in the presence of 0.2T to 3T magnets and fully operational up to the 10,000-line for the MRidium 3860+ MRI compatible IV infusion pump and15,000 gauss-line for the MRidium 3870 MRI compatible IV infusion pump.

● Available with a Dose Error Reduction System (“DERS”) to reduce the risk of medication errors and simplify clinician monitoring.

● Available with a wireless remote display/control providing clinicians and technicians control and visibility from outside of the MRI scanner room.

● Available with an add-on channel (3861 Side Car Module) allowing for the easy addition of a second IV line for patients requiring multiple IV medications at a low incremental cost to the hospital.

● Available with a built-in SpO2 monitor using Masimo SET® technology and a specially designed fiber optic SpO2 sensor allowing one device to monitor oxygen saturation levels while safely providing IV infusion during an MRI procedure.

Our MRI compatible IV infusion pump system includes the 3860+ MRI compatible IV infusion pump, proprietary single-use IV tubing sets, a non-magnetic pole and a lithium battery.

In addition, we offer optional upgrade systems including the 3861 Side Car, 3865 Remote Display/Control, DERS and an SpO2 monitor as discussed below.

Our MRI compatible IV infusion pump systems include the MRI compatible IV infusion pump, proprietary single-use IV tubing sets, a non-magnetic pole and a lithium battery.

In addition, we offer optional upgrade systems as discussed below.

MRidium 3870 MRI Compatible IV Infusion Pump

The MRidium 3870 MRI compatible IV infusion pump was introduced in 2025 with a completely revamped design that improved upon the performance and features of our second generation MRidium 3860+ MRI compatible IV infusion pump.

The MRidium 3870 infusion pump system operates reliably in the presence of 0.2T to 3T magnets and is fully operational up to the 15,000 gauss-line.

This means our MRidium 3870 is highly versatile and can operate virtually anywhere in the MRI scanner room, including up to the entrance of the MRI system bore.

The MRidium 3870 MRI compatible IV infusion pump system has a state-of-the-art color touchscreen graphical user interface (GUI) designed to assist the user throughout the infusion process.

The pumping range of 0.4 mL per hour to 1,000 mL per hour provides a broad range of fluid flow control.

Our range of infusion rates offered supports the ability to administer IV fluids during MRI scans which can relax patients with anxiety and/or claustrophobia, or to provide critical medically necessary drugs such as vasopressors, vasodilators, and anti-coagulants.

Our ability to provide infusions during MRI scans is also beneficial in reducing patient motion, particularly in neonates, children, or patients with neuromuscular disorders, which leads to improved imaging results.

MRI sedation may also be medically necessary to reduce pain or lessen discomfort of patients requiring MRI scans.

Our MRidium 3870 MRI compatible IV infusion pump system offers our DERS drug library allowing clinicians to select a hospital pharmacy designed and approved pre-programmed drug protocol for infusions.

This DERS feature allows the hospital’s pharmacy to determine various concentration and dosage parameters, enable or disable loading, bolus or keep vein open (KVO) functionality, and apply any pharmacy defined preset high and low dosage limits reducing the risk of infusion dosing errors.

The MRidium 3870 MRI compatible IV infusion pump system is equipped with audible and visual alarms and can operate on its rechargeable battery for greater than 8-hours when

infusing at rates of 125 mL per hour.

The 3870 MRI compatible IV infusion pump is also intended to be used during transport within the clinical environment as part of the periprocedural care before and after MRI exams.

MRidium 3860+ MRI Compatible IV Infusion Pump

The MRidium 3860+ MRI compatible IV infusion pump was introduced in 2009 and improved upon the performance and features of our first generation MRidium 3850 MRI compatible IV infusion pump.

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The 1058 extension set includes one needle-free injection port and is typically used to provide uninterrupted critical medications to a severely ill patient during an MRI procedure.

● MRidium 1059 Syringe Adapter Infusion Set.

Our syringe adapter IV set enables users to provide accurate delivery of IV fluids directly from standard syringes.

The 1059 vented syringe adapter set benefits from a low priming volume of 5 ml, which minimizes inefficient waste of medication, and has an additional seven inches in length compared to our 1057 syringe adapter IV set.

This product is most commonly used for cardiac medications, anesthesia, and pediatric drug delivery.

We offer a fully functional and weighted non-magnetic IV pole that is designed for mobility within the hospital and the MRI scanner room.

The IV pole can support two MRidium 3860+ MRI compatible IV infusion pumps, each with a 3861 Side Car Pump Module.

The IV pole is 66 inches (1.68 meters) high, stabilized with a wide pole radius and mobilized with five casters designed to roll easily during transport.

The IV pole can support up to four MRidium 3870 MRI compatible IV infusion pump channels or two MRidium 3860+ MRI compatible IV infusion pumps, each with a 3861 Side Car Pump Module.

pole is 66 inches (1.68 meters) high, stabilized with a wide pole radius and mobilized with five casters designed to roll easily during transport.

The IV pole is equipped with four hooks for holding fluid bags.

Optional Features

Our 3860+ MRI compatible IV infusion pump system gives customers the ability to adapt their systems to meet their specific needs.

In addition to our standard product features, we also offer system upgrades, which include a modular add-on second IV channel through our 3861 Side Car, a wireless remote control/display, DERS and an imbedded SpO2 monitor.

We also offer rechargeable lithium polymer battery packs which have a 12-hour life when not connected to an electrical outlet.

Our MRI compatible IV infusion pump systems gives customers the ability to adapt their systems to meet their specific needs.

In addition to our standard product features, we also offer system upgrades, which include a modular add-on second IV channel for our MRidium 3860+ through our 3861 Side Car, and up to three additional channels with our MRidium 3870, as well as a wireless remote control/display, DERS, and SpO2 monitor.

We also offer rechargeable lithium polymer battery packs which have up to a 12-hour life when not connected to an electrical outlet.

3861 Side Car Pump Module

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The additional delivery line has all of the same features and benefits as the 3860+ MRidium MRI compatible IV infusion pump, as described above.

3865 MRidium Wireless Remote Display/Control

Our wireless remote display/control unit allows for complete control and monitoring of the MRidium MRI compatible IV infusion pump system from the control room (outside of the MRI scanner room).

The 3865 MRidium Wireless Remote relays all commands via a single channel and displays information bi-directionally between the MRI compatible IV infusion pump and the remote display/control unit.

3875 and 3865 MRidium Wireless Remote Display/Control

Our 3875 MRidium Remote Display Unit allows for complete control and monitoring of the MRidium 3870 MRI Infusion Pump providing the clinical user with continuous visual, audible, and remote control from within the control room (outside of the MRI scanner room) .

The MRidium 3875 Remote Display Unit utilizes a similar user interface as the MRidium 3870 MRI Infusion Pump and when placed in the MRI control room allows for continuous clinical user visualization and interaction of all infusion parameters, volume to be infused, IV, time and alarm messages as well as audible and visual alarm notifications.

The MRidium 3875 Remote Display Unit provides continuous visualization of up to four MRidium 3870 MRI Infusion Pumps simultaneously.

The MRidium 3870 MRI Infusion Pump can only communicate, using a proprietary point-to-point, non-network radio and firmware, with a companion 3875 Remote Display Unit with the same link password and channel selection.

Our MRidium 3865 Wireless Remote also allows for complete control and monitoring of the MRidium 3860+ MRI compatible IV infusion pump from the control room The MRidium 3865 Wireless Remote relays all commands via a single channel and displays information bi-directionally between the MRI compatible IV infusion pump and the remote display/control unit.

Utilizing the same user interface and large bright display as the MRidium pump, our wireless remote display/control unit permits clinicians to adjust all pump parameters, including SpO2 monitoring parameters, rates, dose, volume, pump run/stop, alarms (adjust or reset), as well as real-time titration.

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Clinicians may also use the remote display/control unit to adjust a second pump channel when used in combination with our Side Car unit discussed above.

Our 3865 MRidium Wireless Remote also functions as a battery charger for our MRidium battery pack.

Our MRidium Wireless Remotes also functions as a battery charger for our MRidium battery pack.

Dose Error Reduction System (DERS)

Our DERS software for use with our MRidium 3860+ MRI compatible IV infusion pump system incorporates the latest dosing safety features for patients.

Our DERS software for use with our MRidium MRI compatible IV infusion pump systems incorporates the latest dosing safety features for patients.

The DERS system enables users to create a unique drug library and establish nominal values and limits for dose and concentration for specified infusion protocols.

With DERS, patient safety and user convenience are supported by user-programmed infusion hard limits (maximum and minimum) and soft limits (high and low limits that require user confirmation to exceed).

The dose applied via DERS is displayed and can be

adjusted directly on the running screen at any time during the infusion.

The memory card port allows for easy archiving and updating of the drug library.

The dose applied via DERS is displayed and can be adjusted directly on the running screen at any time during the infusion.

The memory card allows for easy archiving and updating of the drug library.

SpO2 Monitoring with Sensor and Accessories

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The method of patient attachment uses a medical-grade silicone rubber sensor grip that allows easy and convenient attachment to the patient’s hand or foot, and accommodates pediatric, adult, and infant patients with various size grips.

We believe our MRidium 3860+ MRI compatible IV infusion pump system and its customizable features comprehensively and uniquely address the needs of MRI departments within hospitals and other medical facilities.

We believe our MRidium 3870 and 3860+ MRI compatible IV infusion pump system and its customizable features comprehensively and uniquely address the needs of MRI departments within hospitals and other medical facilities.

MRI Compatible Patient Vital Signs Monitoring System

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IRadimed FMD1 with RALU

Our 3600 ferromagnetic detection device, IRadimed FMD1 with RALU is the first ferromagnetic detection device with Tru Sense TM threat qualification technology.

Our patent pending Tru Sense TM technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and Zone IV door status.

with IRadimed’s expertise in Dynamic Signal Processing.

Our 3600 FMD, IRadimed FMD1 with RALU is the first FMD with Tru Sense TM threat qualification technology.

Our patented Tru Sense TM technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and Zone IV door status with IRadimed’s expertise in Dynamic Signal Processing.

This technology reduces false alarms, all while simultaneously circumventing background magnetic field noise.

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patent applications pending.

These patents and patent applications relate to several of our products, including our MRI compatible IV infusion pump system and its components and our MRI compatible patient vital signs monitoring system.

These patents and patent applications relate to our product technologies.

We intend to file patent applications with respect to future patentable developments and improvements when we believe that seeking such protection is in our best interest.

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Year Ended December 31,

Disposable, service and other

Amortization of extended warranty agreements

Amortization of extended maintenance agreements

Service and other

Selling cycles for our devices have varied widely and have historically ranged between three and six months in duration.

The principal customers for our MRI compatible products include hospitals and acute care facilities.

The key decision maker in a purchase varies on the hospital department making the purchase.

The principal customers for our MRI compatible products include hospitals and acute care facilities with MR equipment on site.

The key decision maker in a purchase varies depending on the hospital department making the purchase.

We serve these customers through our sales and service specialists and believe that our specialists are well-positioned to build upon these customer relationships.

We communicate with our customers on a regular basis to understand potential issues or concerns as well as to improve our products and services in response to their needs.

Product orders and inquiries are handled by trained service representatives who communicate with customers after equipment shipments, installations, and service repair

Product orders and inquiries are handled by trained service representatives who communicate with customers after

equipment shipments, installations, and service repair calls.

We have implemented various other programs which enable us to assess our customers’ needs.

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Manufacturing and Suppliers

We assemble our products in our facility in Winter Springs, Florida, from components and sub-assemblies purchased from outside suppliers.

We assemble our products in our new facility, which opened in 2025, in Orlando, Florida (“New Facility”), from components and sub-assemblies purchased from outside suppliers.

We perform final assembly, testing and packaging to control quality and manufacturing efficiency.

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We have never encountered a significant supply interruption from any sole supplier;

however, the operations of our third-party suppliers could be disrupted by conditions unrelated to our business operations or that are beyond our control, including but not limited to the global supply chain issues, international trade restrictions and tariffs, excessive demand creating shortages of available supply, and conditions related to health pandemics.

We continuously monitor our supply chain regarding these matters to anticipate and prevent risk of disruption.

We typically maintain no less than a three-month supply of raw materials and parts that are sourced from sole suppliers and make efforts to identify additional suppliers who may be able to provide such raw materials or parts.

For example, the non-magnetic, ultrasonic motor which drives our MRI compatible IV infusion pump was sole sourced from a major multinational Japanese manufacturing company until December 2024 when the Company in its ordinary course of business entered into a technology transfer and license agreement with the supplier allowing the Company to manufacture its own non-magnetic, ultrasonic motors.

For example, the non-magnetic, ultrasonic motor which drives our MRI compatible IV infusion pump was sole sourced from a major multinational Japanese manufacturing company until December 2024 when the Company chose to enter into a technology transfer and license agreement with the supplier allowing the Company to manufacture its own non-magnetic, ultrasonic motors.

We place significant emphasis on providing quality products and services to our customers.

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We believe that a company’s reputation for producing accurate, reliable, and technologically advanced products, references from users, features (speed, safety, ease of use, patient convenience and range of applicability), product effectiveness and price are the principal competitive factors in the medical products industry.

Our SpO2 products, which measure blood oxygen saturation and included in our MRI compatible IV infusion pump and our MRI compatible vital signs monitor, also compete indirectly with many other methods currently used to measure blood oxygen levels or the effects of low blood oxygen levels.

Our SpO2 products, which measure blood oxygen saturation and are included in our MRI compatible IV infusion pump and our MRI compatible vital signs monitor, also compete indirectly with many other methods currently used to measure blood oxygen levels or the effects of low blood oxygen levels.

MRidium MRI Compatible IV Infusion Pump System

We do not believe there is currently any direct competition for our MRI compatible IV infusion pump system.

Historically, our only direct competitor in the MRI compatible IV infusion pump market, Bayer Radiology, formerly MEDRAD, Inc., announced during 2013 its decision to remove its competing Continuum pump system from the market, and discontinued support throughout the world in June 2015 due to ongoing regulatory issues.

As a result, we believe that our MRidium 3860+ MRI compatible IV infusion pump is the only true MRI compatible IV infusion pump available today.

We do not believe there is currently any direct competition for our MRI compatible IV infusion pump systems.

As a result, we believe that our MRidium 3870 and 3860+ MRI compatible IV infusion pumps are the only true MRI compatible IV infusion pumps available today.

The medical device and IV infusion market is highly regulated and is typically one of the areas that the FDA scrutinizes closely for new market introductions.

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There are many manufacturers of conventional IV infusion pump devices, and if any of these manufacturers, or other potential competitors, decide to enter the MRI compatible IV infusion pump market, they may have competitive advantages over us.

Many of these potential competitors have established reputations, customer relationships and marketing, distribution, and service networks.

Many of these potential competitors have established reputations, customer relationships and

marketing, distribution, and service networks.

In addition, they have substantially longer histories in the medical products industry, larger product lines and greater financial, technical, manufacturing, management, and research and development resources.

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There are several manufacturers that have developed competing MRI compatible vital signs monitoring systems that are currently on the market.

We believe the dominant competitor with a market-leading position in MRI compatible vital signs monitoring is Invivo Research, which was founded by Roger Susi, our founder, President, Chief Executive Officer, and Chairman of the Board.

We believe the dominant competitor with a market-leading position in MRI compatible vital signs monitoring is Invivo Research, which was founded by Roger Susi, our founder, President, and Chief Executive Officer, and Chairman of the Board.

Invivo Research is now owned by Koninklijke Philips NV (NYSE:

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Our research and development efforts are driven by the leadership of our founder, President, Chief Executive Officer, and Chairman of the Board, Roger Susi, along with engineers and technical professionals with significant experience in systems engineering and product design.

Our research and development expenses remain consistent at $2.8 million or 3.9 percent of revenue in 2024 and $2.9 million or 4.4 percent of revenue in 2023.

Our research and development expenses remain consistent at $3.0 million, or 3.5 % of revenue in 2025, and $2.8 million or 3.9 % of revenue in 2024.

Human Capital

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We have not experienced any work stoppages and consider our relations with our employees to be good.

We endeavor to maintain a workplace that is free from discrimination or harassment on the basis of color, race, sex, national origin, ethnicity, religion, age, disability, sexual orientation, gender identification or expression or any other status protected by applicable

We conduct annual training to reduce risks of harassment and discrimination and monitor employee conduct year-round, including by providing employees with access to an anonymous whistleblower hotline to report any allegations.

The basis for recruitment, hiring, development, training, compensation, and advancement at the Company is qualifications, performance, skills and experience.

The basis for recruitment, hiring, development, training, compensation, and advancement at the Company is

qualifications, performance, skills and experience.

Our employees are fairly compensated, without regard to gender, race and ethnicity, and routinely recognized for outstanding performance and provided with training and professional development opportunities.

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The development, manufacture, sale and distribution of our medical device products are subject to comprehensive governmental regulation.

Most notably, all our medical devices sold in the United States are subject to the Food, Drug, and Cosmetic Act of 1938, as amended (“FDC Act”), as implemented and enforced by the FDA.

Most notably, all our medical devices sold in the United States are subject to the Federal Food, Drug, and Cosmetic Act of 1938, as amended (“FDC Act”), as implemented and enforced by the FDA.

The FDA, and in some cases other government agencies, such as the U.S.

Federal Communications Commission (“FCC”), administer requirements covering the design, testing, safety, effectiveness, manufacturing, labeling, promotion and advertising, distribution, and post-market surveillance of our products.

Unless an exemption applies, each medical device that we market must first receive either premarket notification clearance (by making what is commonly called “a 510(k) submission”) or premarket approval (by filing a premarket approval application (“PMA”) from the FDA pursuant to the FDC Act).

Unless an exemption applies, each defined medical device that we market must first receive either premarket notification clearance (by making what is commonly called “a 510(k) submission”) or premarket approval (by filing a premarket approval application (“PMA”) from the FDA pursuant to the FDC Act).

In addition, certain modifications made to marketed devices also may require 510(k) clearance or approval of a PMA supplement.

The FDA’s 510(k) clearance process varies in length and can extend beyond twelve months.

The FDA’s 510(k) clearance process varies in length and often extends beyond twelve months.

The process of obtaining PMA approval is much more costly, lengthy, and uncertain than the 510(k) process.

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We cannot be sure that future medical devices or modifications of current medical devices will qualify for the 510(k) pathway or whether PMA approval will be required for any future product that we propose to market.

An exception is our FMD1, which does not fall under FDA regulation as it does not meet the definition of a medical device per section 201 (h) of the Food, Drug, and Cosmetic Act.

An exception is our FMD1 (Ferrous Metal Detector), which does not fall under FDA regulation as it does not meet the definition of a medical device per section 201 (h) of the FDC Act.

In December 2014, the FDA issued guidance entitled “Infusion Pumps Total Product Life Cycle.” This guidance established substantial additional pre-market requirements for new and modified infusion pumps.

Through this guidance, the FDA required more data needed to demonstrate product safety for future 510(k) submissions for infusion pumps, including the potential for more clinical and human factors data.

The impact of this guidance is likely to result in a more time consuming and costly process to obtain regulatory clearance to market infusion pumps.

In addition, new requirements beyond the 2014 guidance document could result in longer delays for the clearance of new products, modification of existing infusion pump products or remediation of existing products in the market.

The impact of this guidance results in a more time-consuming and costly process to obtain regulatory clearance to market infusion pumps.

In addition, new requirements beyond the 2014 FDA guidance could result in longer delays for the clearance of new products, modification of existing infusion pump products or remediation of existing products in the market.

Future delays in the receipt of, or failure to obtain, approvals could result in delayed or no realization of attendant product revenues.

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labeling requirements and FDA prohibitions against the promotion of off-label uses or indications;

adverse event reporting;

event reporting;

post-approval restrictions or conditions, including post-approval study commitments;

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While we conduct informal oversight to detect and prevent these types of fraud and abuse, we lack formal written policies and procedures at this time.

If we were unable to document and implement the controls and procedures required in a timely manner or otherwise violate such laws, we might suffer adverse regulatory consequences or face criminal sanctions, which could harm our operations, financial reporting, or financial results.

Regulation of Medical Devices Outside of the United States

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Currently, the regulatory requirements for a broad spectrum of medical devices are covered in three European Medical Device Directives (adopted in the 1990’s) with which manufacturers must comply in order to receive a CE Certificate of Conformity (“CE Mark”) from a Notified Body.

Only certified medical devices bearing a CE Mark can be sold in the EU and European Free Trade Association (“EFTA”) countries and Türkiye.

Only certified medical devices bearing a CE Mark can be sold in the EU, the European Free Trade Association (“EFTA”) countries and Türkiye.

EFTA includes Iceland, Norway, Principality of Liechtenstein and Switzerland.

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Compliance with the MDR will require re-certification of our products to the enhanced standards and may result in substantial additional expense.

If these measures are unable to be taken, it may no longer be possible to place such devices on the EU market.

Additionally, we may lose our current quality system certification due to ISO Registrar difficulties as European authorities increase regulatory pressure or increased scrutiny resulting from MDR.

If these measures are unable to be met, it may no longer be possible to place such devices on the EU market.

Additionally, we may lose our current quality system certification due to ISO Registrar difficulties as European authorities increase regulatory pressure or increase scrutiny resulting from MDR.

The loss of the quality system certification may prevent product shipments to the EU and to other foreign markets, such as Canada, which could significantly lower our revenues from foreign sales while we take remedial measures.

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Available Information

Our principal executive office is located at 1025 Willa Springs Drive, Winter Springs, Florida 32708.

Our principal executive office is located at 12705 Ingenuity Drive, Orlando, Florida 32826.

Our telephone number is (407) 677-8022, and our website address is https://www.iradimed.com.

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We routinely post these reports, recent news and announcements, financial results and other important information about our business on our website at https://www.iradimed.com.

Information contained on our website is not a part of this Annual Report.

Information contained on our website is not a part of this Annual Report and is not incorporated into this Annual Report.

In addition, the SEC maintains an Internet website at www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.

2 unchanged sentences

A current copy of the Code of Ethics is posted on the Governance section of the Investors page of our website, which is located at www.iradimed.com.

We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding any

substantive amendment to, or waiver from, a provision of the Code of Ethics by posting such information on our website address at https://www.iradimed.com.

We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding any substantive amendment to, or waiver from, a provision of the Code of Ethics that apply to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions, by posting the required information on our corporate website address at https://www.iradimed.com.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business