−Removed: IRADIMED CORPORATION (“IRADIMED”, the “Company”, “we”, “us”, “our”) develops, manufactures, markets and distributes Magnetic Resonance Imaging (“MRI”) compatible medical devices and accessories and services relating to them.
+Added: IRADIMED CORPORATION (“IRADIMED”, the “Company,” “we,” “us,” “our”) develops, manufactures, markets and distributes Magnetic Resonance Imaging (“MRI”) compatible medical devices and related accessories, disposables and services relating to them.
We were incorporated in Oklahoma in July 1992 and reincorporated in Delaware in April 2014.
MRidium 3860+ MRI Compatible IV Infusion Pump System
−Removed: We are the only known provider of a non-magnetic Intravenous (“IV”) infusion pump system that is specifically designed for safe use during MRI procedures.
+Added: We are the only known provider of a non-magnetic intravenous (“IV”) infusion pump system that is specifically designed to be safe for use during MRI procedures.
We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures.
−Removed: Standard infusion pumps contain magnetic and electronic components which can create radio frequency (“RF”) interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system.
−Removed: 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 medications or fluids during various MRI procedures.
−Removed: 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 or life sustaining medications, and children and infants who must generally be sedated to remain immobile during an MRI scan.
+Added: 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.
+Added: 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.
+Added: 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.
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As of December 31, 2021, we have sold approximately 6,062 MRI compatible IV infusion pump systems and approximately 1,138 of our 3880 MRI compatible patient vital signs monitoring systems.
−Removed: We generate revenue from the sale of MRI compatible medical devices and accessories, extended warranty agreements, services related to maintaining our products and the sale of disposable products used with our devices.
−Removed: In fiscal year 2020, our revenue was $31.7 million and our loss from operations was $(0.8) million representing an operating profit margin of (2.4) percent.
+Added: 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.
+Added: In fiscal year 2021, our revenue was $41.8 million and our income from operations was $9.8 million representing an operating profit margin of 23.5 percent.
Refer to the information contained under the caption “Financial Highlights and Outlook” regarding our outlook for 2022.
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Intravenous fluids and vital signs monitoring are needed during MRI procedures for many different reasons.
−Removed: Infusion pumps provide sedation to patients who are not able to remain immobile during an MRI scan and a continuous flow of critical medications to seriously ill patients, including those from critical care departments.
+Added: 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.
Given the benefits to patient safety, radiology departments performing the scan, anesthesia departments delivering sedation and critical care specialists responsible for delivering critical medications during MRI procedures often initiate requests for an MRI compatible IV infusion pump.
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The major problem with this approach is that a highly magnetic standard IV infusion pump is still being introduced into a hazardous MRI environment, which can lead to projectile accidents.
−Removed: Additionally, placing a highly
−Removed: magnetic standard IV infusion pump inside a shielded box hinders an operator’s ability to determine the pump’s status and creates inefficiencies when addressing an alarm or revising a pump’s flow rate.
+Added: Additionally, placing a highly magnetic standard IV infusion pump inside a shielded box hinders an operator’s ability to determine the pump’s status and creates inefficiencies when addressing an alarm or revising a pump’s flow rate.
Moreover, a Faraday cage with a standard IV infusion pump must be kept approximately 5 to 10 feet from the scanner, which may result in the use of long IV lines.
By contrast, our MRI compatible IV infusion pump system can be safely placed anywhere in the scanner room including next to the scanner.
−Removed: We are not aware of any “shielded box” installations in use in the U.S.
We believe that our MRidium MRI compatible IV infusion pump system is the first and only product to provide an easy-to-operate, non-magnetic, safe and RF-quiet solution and hence a truly MRI compatible product.
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Historically, we marketed our MRI compatible devices primarily to the MRI departments of U.S.
−Removed: We believe, however, based on feedback and historical successes selling our devices, that there is potential for expanded deployment of our MRI compatible IV infusion pumps and MRI compatible monitors within the Intensive Care Unit (“ICU”), Emergency Room (“ER”), and other critical care departments within U.S.
+Added: We believe, however, based on feedback and historical successes selling our devices, that there is continued potential for expanded deployment of our MRI compatible IV infusion pumps and MRI compatible monitors within the Intensive Care Unit (“ICU”), Emergency Room (“ER”), and other critical care departments within U.S.
hospitals where there is a high probability that MRI procedures will need to be performed on these patients.
−Removed: Expanded use of our MRI compatible medical devices would 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.
+Added: These additional call points within the critical care areas of a hospital often result in additional sales into radiology.
+Added: 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.
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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Company Objective
−Removed: Our objective is to become the leader in providing safe and effective care for all patients undergoing MRI procedures through the development and commercialization of a portfolio of MRI compatible products, accessories and related services.
+Added: Our objective is to become the leader in providing safe and effective care for all patients undergoing MRI procedures through the development and commercialization of a portfolio of MRI compatible products, accessories, disposables, and related services.
By increasing the safety parameters of equipment operating within the harsh magnetic environment of the MRI scanner room, we hope to enable hospitals and other healthcare providers to offer the MRI diagnostic procedures patients require.
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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.
−Removed: Our 3880 Monitor’s compact and lightweight design facilitates 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.
+Added: 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.
Because of the transport capabilities that only our 3880 Monitor offers, we believe multiple departments within a hospital will be interested in purchasing our device.
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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 infusion pump solution and the shortcomings of current workaround practices.
−Removed: Additionally, with our 3880 Monitor, we focus on educating customers on the total workflow benefits our devices offer and how our devices increase patient safety through their combined transport capabilities.
−Removed: 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.
+Added: 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.
+Added: In recent years, we have decreased the size of our commercial teams while increasing their collective efficiencies.
+Added: As business progress dictates, we intend to add to our specialized, MRI product-focused direct sales team, including our supporting clinical application specialists.
+Added: 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 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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MRidium MRI Compatible IV Infusion Pump System
−Removed: The patented MRidium MRI compatible IV infusion pump system is based upon a non-magnetic, ultrasonic motor and other uniquely designed non-ferrous parts in order to provide accurate and dependable fluid delivery to patients undergoing an MRI procedure.
+Added: 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.
Our MRidium MRI compatible IV infusion pump system has been designed to offer numerous advantages to hospitals, clinicians, and patients.
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● MRidium 1058 Extension Infusion Set.
−Removed: Our extension infusion set allows users to transfer a patient on a non-MRI infusion pump to our MRidium MRI compatible IV infusion pump.
−Removed: The user simply disconnects the existing IV tubing at the patient site and connects and primes the MRidium extension set to the existing IV tubing.
+Added: Our extension infusion set allows users to transfer a patient on a standard infusion pump to our MRI compatible IV infusion pump.
+Added: The user simply disconnects the existing IV tubing at the patient site and primes and connects the MRidium extension set to the existing IV tubing.
Once removed from the conventional infusion pump and connected to our MRidium MRI compatible IV infusion pump, the user can program the pump and begin the infusion.
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3865 MRidium Wireless Remote Display/Control
−Removed: Our wireless remote 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).
−Removed: The 3865 MRidium Wireless Remote relays all commands and displays information bi-directionally between the MRI compatible IV infusion pump and the remote control unit.
−Removed: Utilizing the same user interface and large bright display as the MRidium pump, our wireless remote 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.
−Removed: Our remote control unit utilizes a proven MRI compatible 2.4 GHz frequency hopping spread spectrum radio technology for artifact-free operation that does not disturb the MRI imaging process.
−Removed: Clinicians may also use the remote control unit to adjust a second pump
−Removed: channel when used in combination with our Side Car unit discussed above.
+Added: 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).
+Added: The 3865 MRidium Wireless Remote relays all commands and displays information bi-directionally between the MRI compatible IV infusion pump and the remote display/control unit.
+Added: 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.
+Added: Our remote display/control unit utilizes a proven MRI compatible 2.4 GHz frequency hopping spread spectrum radio technology for artifact-free operation that does not disturb the MRI imaging process.
+Added: 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.
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MRI Compatible Patient Vital Signs Monitoring System
−Removed: Our 3880 Monitor has been designed with non-magnetic components and other special features in order to safely and accurately monitor a patient’s vital signs during various MRI procedures.
+Added: Our 3880 Monitor has been designed with non-magnetic components and other special features to safely and accurately monitor a patient’s vital signs during various MRI procedures.
The 3880 Monitor system is fully operational in magnetic fields up to 30,000 gauss, which means it can operate virtually anywhere in the MRI scanner room (see above diagram).
−Removed: Our 3880 Monitor has a compact, lightweight design allowing it to travel with the patient 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.
+Added: Our 3880 Monitor has a compact, lightweight design allowing it to travel with the patient from the 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.
The basic configuration of the 3880 Monitor includes wireless ECG with dynamic gradient filtering;
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Because of the uncertainty of order cancellations or rescheduling, we do not believe our backlog as of any particular date is indicative of actual sales for any future period and, therefore, should not be used as a measure of future revenue.
−Removed: For the years ended December 31, 2020, 2019 and 2018, backlog was approximately:
−Removed: Years ended December 31,
+Added: At December 31, 2021, 2020 and 2019, our backlog was approximately:
(In millions)
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We serve these customers through our sales and service specialists and believe that our specialists are well-positioned to build upon these customer relationships.
−Removed: We communicate with our customers on a regular basis in an attempt to understand potential issues or concerns as well as to improve our products and services in response to their needs.
+Added: 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 calls.
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These programs include surveys and visits to customer sites.
−Removed: We enter into agreements with healthcare supply contracting companies, commonly referred to as Group Purchasing Organizations (“GPOs”) in the U.S., which enable us to sell and distribute our products to their member hospitals.
+Added: We enter into agreements with integrated delivery health systems and healthcare supply contracting companies, which are commonly referred to as Group Purchasing Organizations (“GPOs”) in the U.S., which enable us to sell and distribute our products to their member hospitals.
GPOs negotiate volume purchase prices for hospitals, group practices, and other clinics that are members of a GPO.
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● Payment of administrative fees by us to the GPO, based on purchases of our products by group members.
−Removed: Under these agreements, we are required to pay the GPOs a fee of three percent of the sales of our products to members of the GPO.
+Added: Under our GPO agreements, we are required to pay the GPOs a fee of three percent of the sales of our products to members of the GPO.
Manufacturing and Suppliers
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however, there can be no assurance that this trend will continue or that we will be able to produce sufficient units to reach our expected revenue growth rates.
−Removed: Some of the raw materials and parts that are critical to the production and operation of our products are sourced from single suppliers and some components we or our suppliers utilize are from Chinese manufacturers.
+Added: Some of the raw materials and parts that are critical to the production and operation of our products are sourced from single suppliers.
+Added: Some components we or our suppliers utilize are from Chinese manufacturers.
We have never encountered a significant supply interruption from any sole supplier;
−Removed: 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 international trade restrictions, excessive demand creating shortages of available supply, and conditions related to COVID-19 or other epidemics.
−Removed: We are unsure whether an extended period of general supplier disruption caused by COVID-19 will affect us directly or through our suppliers;
−Removed: however, we continue to monitor our supply chain regarding the matter.
+Added: 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 on-going global supply chain issues, international trade restrictions, excessive demand creating shortages of available supply, and conditions related to COVID-19 or other epidemics.
+Added: We are unsure whether an extended period of general supplier disruption caused by COVID-19 or these other events, will affect us directly or through our suppliers;
+Added: however, we continue to monitor our supply chain regarding these matters.
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.
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In January 2007, we received ISO 13485 certification and met the requirements under the European Medical Device Directive to use the CE Mark, thereby allowing us to continue to market our products in the European Community.
−Removed: In January 2018 we underwent an audit to update our ISO 13485:2016 and Medical Device Single Audit Program certifications and received our certificates in November 2018.
+Added: In October 2021, we underwent a recertification audit to maintain our ISO 13485:2016 and Medical Device Single Audit Program certifications and received our certificates.
These certificates will need renewal again in January 2023.
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This long development timeline coupled with the low market penetration to date may discourage new competitors from undertaking a complex project like building an MRI compatible IV infusion pump.
−Removed: We believe that the market for MRI compatible IV infusion pump products is in relatively early stages of development and may become highly competitive if, and when, the market develops further.
+Added: We believe that the market for MRI compatible IV infusion pump products is underpenetrated and may become highly competitive if, and when, the market develops further.
We also compete with manufacturers of “shielded box” solutions that are intended to permit use of conventional IV pumps inside the MRI scanner room.
The providers of shielded boxes include B.
−Removed: Braun, Fresenius Kabi, MIPM Mammendorfer Institut für Physik und Medizin and Arcomed.
+Added: Braun, Fresenius Kabi and MIPM Mammendorfer Institut für Physik und Medizin.
Many of our potential customers opt not to purchase our MRI compatible IV infusion pump systems and instead use makeshift workarounds, such as placing conventional IV infusion devices outside of the MRI scanning room and utilizing extension tubing to reach the patient.
To this extent, we are in competition with conventional IV infusion pump manufacturers and distributors.
−Removed: There are many manufacturers of conventional IV infusion pump devices, and if any of these manufacturers, or other potential competitors, decide to enter into the MRI compatible IV infusion pump market, they may have competitive advantages over us.
+Added: 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.
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Our third quarter sales have typically been lower, compared to other fiscal quarters, principally because the fiscal quarter coincides with the summer vacation season, in the U.S., Europe and Japan.
−Removed: Additionally, COVID-19 may create changes to customer buying patterns that vary from the historical trend.
+Added: Additionally, COVID-19 may continue creating changes to customer buying patterns that vary from the historical trend.
Segment Information and Geographic Data
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Our research and development expenses were $1.9 million or 4.6 percent of revenue in 2021, $1.9 million or 6.0 percent of revenue in 2020 and $1.4 million or 3.7 percent of revenue in 2019.
−Removed: As of December 31, 2020, we had 110 full-time employees, including 32 in manufacturing and service, 43 in sales, marketing and customer support services, 15 in regulatory affairs and quality assurance, 11 in finance and
−Removed: administration and 9 in research and development.
+Added: As of December 31, 2021, we had 110 full-time employees, including 38 in manufacturing and service, 41 in sales, marketing and customer support services, 10 in regulatory affairs and quality assurance, 12 in finance and administration and 9 in research and development.
No employees are represented by a labor union.
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We have compliance programs in place to support and monitor compliance with these laws and regulations.
−Removed: All of our products and facilities and those of our suppliers are subject to drug and medical device laws and regulations promulgated by the FDA and national and supranational regulatory authorities outside the U.S., including, for example, Health Canada’s Health Products and Foods Branch, the U.K.’s Medicines and Healthcare Products Regulatory Agency, and Australia’s Therapeutic Goods Agency.
+Added: All our products and facilities and those of our suppliers are subject to drug and medical device laws and regulations promulgated by the FDA and national and supranational regulatory authorities outside the U.S., including, for example, Health Canada’s Health Products and Foods Branch, the U.K.’s Medicines and Healthcare Products Regulatory Agency, and Australia’s Therapeutic Goods Agency.
These authorities regulate a range of activities including, among other matters, manufacturing, post-marketing studies in humans, advertising and promotion, product labeling, post-marketing surveillance and adverse event reporting.
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The development, manufacture, sale and distribution of our medical device products are subject to comprehensive governmental regulation.
−Removed: Most notably, all of 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.
+Added: 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.
The FDA, and in some cases other government agencies, such as the U.S.
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It generally takes from two to three years or even longer.
−Removed: All of our current products that are available in the U.S.
+Added: All our current medical devices and related products that are available in the U.S.
were originally cleared through the 510(k) process.
−Removed: We cannot be sure that future products or modifications of current products, will qualify for the 510(k) pathway or whether 510(k) clearance or PMA approval will be obtained for any future product that we propose to market.
+Added: We cannot be sure that future medical devices or modifications of current medical devices, will qualify for the 510(k) pathway or whether 510(k) clearance or PMA approval will be obtained for any future product that we propose to market.
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.
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All aspects of our manufacturing and distribution of regulated products and those of our suppliers are subject to substantial governmental oversight.
−Removed: Facilities used for the production, packaging, labeling, storage and distribution of
−Removed: medical devices must be registered with the FDA and other regulatory authorities.
+Added: Facilities used for the production, packaging, labeling, storage, and distribution of medical devices must be registered with the FDA and other regulatory authorities.
All manufacturing activities for these products must be conducted in compliance with current good manufacturing practices (“cGMPs”).
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One such law, the Anti-kickback Statute, prohibits the solicitation, offer, payment or receipt of remuneration in return for referral or purchase, or in return for the recommending or arranging for the referral or purchase, of products covered by the programs.
−Removed: The Anti-kickback Statute provides a number of exceptions or “safe harbors” for particular types of transactions.
+Added: The Anti-kickback Statute provides several exceptions or “safe harbors” for particular types of transactions.
While we generally do not file claims for reimbursement from government payers, the U.S.
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markets in which we do business.
−Removed: These laws range from comprehensive device approval requirements for some or all of our products to requests for product data or certifications.
+Added: These laws range from comprehensive device approval requirements for some or all our products to requests for product data or certifications.
Inspection of and controls over manufacturing, as well as monitoring of device-related adverse events, also are components of most of these regulatory systems.
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For example, the European Union (“EU”), which currently relies on independent third parties, (called “Notified Bodies”) rather than governmental authorities to review and certify medium and high-risk medical devices, is moving to more governmental oversight of medical devices.
−Removed: Currently, the regulatory requirements for a broad spectrum of medical devices are covered in three European
−Removed: 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.
+Added: 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 Turkey.
EFTA includes Iceland, Norway, Principality of Liechtenstein and Switzerland.
−Removed: In May 2017, the European Union (the "EU") implemented a new regulatory scheme for medical devices under the Medical Device Regulation ("MDR").
−Removed: The MDR becomes effective in May 2021, however our CE Certificates are valid through May 2024, allowing us to continue shipping our products into the EU after the effective date of the MDR.
−Removed: MDR will bring significant new requirements for many medical devices, including enhanced requirements for clinical evidence and documentation, increased focus on device identification and traceability, new definitions and registration of economic operators throughout the distribution chain, and additional post-market surveillance and vigilance.
+Added: In May 2017, the European Union (the “EU”) implemented a new regulatory scheme for medical devices under the Medical Device Regulation (“MDR”).
+Added: The MDR became effective in May 2021, however our CE Certificates are valid through May 2024, allowing us to continue shipping our products into the EU after the effective date of the MDR.
+Added: MDR brings significant new requirements for many medical devices, including enhanced requirements for clinical evidence and documentation, increased focus on device identification and traceability, new definitions and registration of economic operators throughout the distribution chain, and additional post-market surveillance and vigilance.
Compliance with the MDR will require re-certification of our products to the enhanced standards and may result in substantial additional expense.
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Since a significant portion of the regulatory framework in the United Kingdom is derived from EU directives and regulations, the referendum could materially impact the regulatory regime with respect to our products in the United Kingdom or the EU.
−Removed: Any delay in obtaining, or an inability to obtain, any device certifications, product marketing approvals, or other regulatory authorizations as a result of Brexit or otherwise, could prevent us from commercializing our products in the United Kingdom and/or the EU and affect our operations and financial results.
−Removed: The ultimate effects of Brexit are uncertain and will depend on any agreements the United Kingdom makes to retain access to EU markets either during a transitional period or more permanently.
+Added: Any delay in obtaining, or an inability to obtain, any device certifications, product marketing approvals, or other regulatory authorizations resulting from Brexit or otherwise, could prevent us from commercializing our products in the United Kingdom and/or the EU and affect our operations and financial results.
+Added: The ultimate effects of Brexit remain uncertain and will depend on any agreements the United Kingdom makes to retain access to EU markets either during a transitional period or more permanently.
Brexit could adversely affect European and worldwide economic and market conditions and could contribute to instability in global financial and foreign exchange markets.
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Because of the predominance of government-sponsored healthcare systems around the world, many of our customer relationships outside of the United States are with governmental entities.
−Removed: Our policies mandate strict
−Removed: compliance with the anti-bribery laws.
+Added: Our policies mandate strict compliance with the anti-bribery laws.
We operate in many parts of the world that have experienced governmental corruption to some degree, and in certain circumstances strict compliance with anti-bribery laws may conflict with local customs and practices.
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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.