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● core laboratory systems in the areas of immunoassay, clinical chemistry, hematology, and transfusion medicine, including the Alinity ® family of instruments, ARCHITECT ® , ABBOTT PRISM ® , and Cell-Dyn ® , with assays used for screening and/or diagnosis for cancer, cardiac, metabolics, drugs of abuse, fertility, general chemistries, infectious diseases such as hepatitis and HIV, therapeutic drug monitoring, and a suite of SARS-CoV-2 serology assays;
−Removed: ● molecular diagnostics polymerase chain reaction (PCR) instrument systems, including Alinity ® m and m2000™ that automate the extraction, purification, and preparation of DNA and RNA from patient samples, and detect and measure infectious agents including HIV, hepatitis, HPV, sexually transmitted infections, and SARS-CoV-2;
−Removed: and products for oncology with the Vysis ® FISH product line of genomic-based tests;
+Added: ● molecular diagnostics polymerase chain reaction (PCR) instrument systems, including Alinity ® m and m2000 ® that automate the extraction, purification, and preparation of DNA and RNA from patient samples, and detect and measure infectious agents including HIV, hepatitis, HPV, sexually transmitted infections, SARS-CoV-2 and influenza A & B, and respiratory syncytial virus (RSV);and products for oncology with the Vysis ® FISH product line of genomic-based tests;
● point of care systems, including the i-STAT ® and next-generation i-STAT ® Alinity ® and cartridges for testing blood gas, chemistry, electrolytes, coagulation and immunoassay;
−Removed: ● rapid diagnostics lateral flow testing products in the area of infectious diseases, including respiratory viruses such as SARS-CoV-2 and influenza, HIV, hepatitis, and tropical diseases such as malaria and dengue fever;
+Added: ● rapid diagnostics lateral flow testing products in the area of infectious diseases such as SARS-CoV-2, including the BinaxNOW ® and Panbio ® rapid testing platforms, influenza, HIV, hepatitis, and tropical diseases such as malaria and dengue fever;
molecular point-of-care testing for HIV, including the m-PIMA ® HIV-1/2 Viral Load Test, and for SARS-CoV-2 and influenza A & B, RSV and strep A, including the ID NOW ® rapid molecular system;
−Removed: cardiometabolic testing, including Afinion ® and Cholestech™ platforms and tests;
+Added: cardiometabolic testing, including Afinion ® and Cholestech LDX ® platforms and tests;
a toxicology business for drug and alcohol testing;
and remote patient monitoring and consumer self-testing;
−Removed: ● informatics and automation solutions for use in laboratories, including laboratory automation systems, the RALS ® point of care solution, and AlinIQ ® , a suite of informatics tools and professional services.
+Added: ● informatics and automation solutions for use in laboratories, including laboratory automation systems such as the GLP track system,the RALS ® point of care solution, and AlinIQ ® , a suite of informatics tools and professional services.
The Diagnostic Products segment’s products are subject to competition in technological innovation, price, convenience of use, service, instrument warranty provisions, product performance, laboratory efficiency, long-term supply contracts, and product potential for overall cost-effectiveness and productivity gains.
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The principal products included in the Nutritional Products segment are:
−Removed: ● various forms of prepared infant formula and follow-on formula, including Similac ®* , Similac Pro-Advance ®* , Similac ® Advance ® , Similac ® Advance ® Non-GMO, Similac Pro-Sensitive ®* , Similac Sensitive ® , Similac Sensitive ® Non-GMO, Go&Grow by Similac ®* , Similac ® NeoSure ® , Similac ® Organic, Similac ® Special Care ® , Similac Total Comfort ®* , Similac ® For Supplementation, Isomil ® Advance ® , Isomil ® , Alimentum ® , Gain™, Grow™, Similac En Mei Li™, and Eleva™;
+Added: ● various forms of infant formula and follow-on formula, including Similac ® , Similac® 360 Total Care®, Similac Pro-Advance ® , Similac ® Advance ® , Similac ® Advance ® Non-GMO, Similac Pro-Sensitive ® , Similac Sensitive ® , Similac Sensitive ® Non-GMO, Go&Grow by Similac ® , Similac ® NeoSure ® , Similac ® Organic, Similac ® Special Care ® , Similac Total Comfort ® , Similac ® For Supplementation, Isomil ® Advance ® , Isomil ® , Alimentum ® , Gain™, Grow™, Similac En Mei Li™, and Eleva™;
● adult and other pediatric nutritional products, including Ensure ® , Ensure Plus ® , Ensure ® Enlive ® , Ensure ® (with NutriVigor ® ), Ensure ® Max Protein, Ensure ® High Protein, Glucerna ® , Glucerna Hunger Smart ® , ProSure™, PediaSure ® , PediaSure SideKicks ® , PediaSure ® Peptide, EleCare ® , Juven ® , Abound™, Pedialyte ® and Zone Perfect ® ;
● nutritional products used in enteral feeding in health care institutions, including Jevity ® , Glucerna ® 1.2 Cal, Glucerna ® 1.5 Cal, Osmolite ® , Oxepa ® , Freego™ (Enteral Pump) and Freego™ sets, Nepro ® , and Vital ® .
−Removed: * These products are available with 2'‐FL HMO (Human Milk Oligosaccharide) in several markets.
Primary marketing efforts for nutritional products are directed toward consumers or to securing the recommendation of Abbott’s brand of products by physicians or other health care professionals.
−Removed: In addition, certain nutritional products sold as Similac ® , Gain™, Grow™, Eleva™, PediaSure ® , PediaSure SideKicks ® , Pedialyte ® , Ensure ® , Zone Perfect ® , and Glucerna ® are also promoted directly to the public by consumer marketing efforts in select markets where appropriate.
+Added: In addition, nutritional products are also promoted directly to the public by consumer marketing efforts in markets where permitted.
Competition for nutritional products in the segment is generally from other diversified consumer and health care manufacturers.
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Ellipse ® , Fortify Assura ® , and Gallant™ implantable cardioverter defibrillators and Gallant and Quadra Assura MP ® implantable cardioverter defibrillator with cardiac resynchronization therapy and MultiPoint ® Pacing technology;
−Removed: and Confirm Rx ® implantable cardiac monitor;
+Added: and Confirm Rx ® and Jot Dx™ implantable cardiac monitors;
● electrophysiology products, including the TactiCath ® family of ablation catheters and FlexAbility ® irrigated ablation catheters;
1 unchanged sentence
EnSite ® family of cardiac mapping systems;
−Removed: and the Advisor ® HD Grid mapping catheter;
−Removed: ● heart failure related products, including the HeartMate™ left ventricular device family and the CardioMEMS ® HF System pulmonary artery sensor, a heart failure monitoring system;
+Added: Agilis™ NxT Steerable Introducer;
+Added: the Advisor ® HD Grid mapping catheter;
+Added: ViewFlex™ family of intracardiac echocardiography catheters;
+Added: and ViewMate™ Ultrasound System;
+Added: ● heart failure related products, including the HeartMate ® left ventricular device family, the CardioMEMS ® HF System pulmonary artery sensor, a heart failure monitoring system, and the CentriMag ® System, an acute circulatory support system;
● vascular products, including the XIENCE ® family of drug-eluting coronary stent systems developed on the Multi-Link Vision ® platform;
−Removed: StarClose SE ® and Perclose ProGlide ® vessel closure devices, TREK ® coronary balloon dilatation products, Hi-Torque Balance Middleweight Universal II ® guidewires, Supera ® Peripheral Stent System, a peripheral vascular stent system;
+Added: StarClose SE ® , Perclose ProGlide ® and Perclose ProStyle ® vessel closure devices, TREK ® coronary balloon dilatation products, Hi-Torque Balance Middleweight Universal II ® guidewires, Supera ® Peripheral Stent System, a peripheral vascular stent system;
Acculink ® /Accunet ® and Xact ® /Emboshield NAV6 ® , carotid stent systems;
−Removed: and the OPTIS ® integrated system with the Dragonfly OPTIS ® imaging catheter and PressureWire ® fractional flow reserve measurement systems;
−Removed: ● structural heart products, including MitraClip ® , a percutaneous mitral valve repair system;
+Added: the OPTIS ® integrated systems with Ultreon™ 1.0 Software, compatible with the Dragonfly OPTIS ® imaging catheter and PressureWire ® fractional flow reserve measurement systems;
+Added: and the JETi™ peripheral thrombectomy systems for clot removal;
+Added: ● structural heart products, including MitraClip ® , a transcatheter mitral valve repair system;
Trifecta ® Valve with Glide™ Technology, a surgical tissue heart valve;
−Removed: Portico ® transcatheter aortic heart valve;
−Removed: Regent™ mechanical heart valve;
+Added: Portico ® and Navitor™ transcatheter aortic heart valves;
+Added: Regent™ mechanical heart valve s ;
Amplatzer ® PFO occluders;
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Abbott purchases, in the ordinary course of business, raw materials and supplies essential to Abbott’s operations from numerous suppliers in the United States and around the world.
−Removed: There have been no recent significant availability problems or supply shortages for raw materials or supplies.
+Added: Due to disruptions to the global supply chain caused in part by the COVID-19 pandemic, Abbott has experienced availability issues with some materials and electronic components.
+Added: To date, Abbott has been able to manage these challenges without significant supply disruptions or shortages for raw materials and supplies.
+Added: A more detailed discussion on the COVID-19 pandemic’s disruption of the global supply chain and its resulting impact on Abbott’s business is contained in “ Abbott is subject to risks related to public health crises, such as widespread outbreaks of infectious diseases like the COVID-19 pandemic.
+Added: ” in “Economic and Industry Risk” under “Item 1A.
+Added: Risk Factors.”
Patents, Trademarks, and Licenses
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Abbott believes that its operations comply in all material respects with applicable laws and regulations concerning environmental protection.
−Removed: Regulations under federal and state environmental laws impose stringent limitations on emissions and discharges to the environment from various manufacturing operations.
+Added: Regulations under federal, state, and various other countries’ environmental laws impose stringent limitations on emissions and discharges to the environment from various manufacturing operations.
Abbott’s capital and operating expenditures for pollution control in 2021 were not material and are not expected to be material in 2022.
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Over 21,000 Abbott employees across 73 countries took part in 2021.
−Removed: During the COVID-19 pandemic, Abbott has taken aggressive steps to limit exposure and enhance the safety of facilities for its employees, including implementing mandatory temperature screening and social distancing, providing and requiring the use of personal protective equipment, and at most U.S.
−Removed: facilities, onsite COVID-19 testing.
+Added: During the COVID-19 pandemic, Abbott has taken aggressive steps to limit exposure and enhance the safety of facilities for its employees, including providing and requiring the use of personal protective equipment and at many facilities, providing vaccinations, providing and requiring onsite COVID-19 testing, and implementing social distancing.
+Added: In some locations, employees also have received free over-the-counter COVID-19 tests for at-home use.
Talent Management
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Abbott ties executive compensation to human capital management, including diversity outcomes, to sustain an inclusive culture and the fair and balanced treatment of Abbott’s employees.
+Added: In 2021, Abbott issued its first-ever diversity, equity, and inclusion report, which describes Abbott’s plans, strategies, and actions to fulfill its commitment to develop an inclusive workplace.
Abbott’s employee networks play an important role in building an inclusive culture across all Abbott operations.
1 unchanged sentence
Abbott has ten such networks, which are:
−Removed: Advancing Professionals Network (supporting early career employees), Asian Leadership and Cultural Network, Black Business Network, Flex Network (employees with part-time and flexible schedules), LA VOICE Network (supporting Hispanic and Latino employees), People with Disabilities Network, PRIDE (supporting LGBTQ employees), Veterans Network, Women Leaders of Abbott, and Women in STEM.
+Added: Advancing Professionals Network (supporting early career employees), Asian Leadership and Cultural Network, Black Business Network, Flex Network (supporting employees with part-time and flexible schedules), LA VOICE Network (supporting Hispanic and Latino employees), disABILITY Network (supporting people with disabilities), PRIDE (supporting LGBTQ employees), Veterans Network, Women Leaders of Abbott, and Women in STEM.
+Added: All Abbott employees are encouraged to join any of the employee networks.
Abbott offers professional development programs, which provide recent college graduates the opportunity to rotate through different areas of Abbott, often with the chance to work outside their home country.
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interns were women and 48% were minorities.
−Removed: Further, Abbott has operated a STEM internship program for high school students in the U.S.
+Added: Further, Abbott has offered a STEM internship program for high school students in the U.S.
+Added: since 2012 and beginning in 2021, students who complete the program are eligible to receive college credit for their experience.
The program’s objective is to increase the number of students pursuing STEM-related careers and contribute to a more diverse talent pipeline for Abbott.
2 unchanged sentences
Abbott is committed to building, retaining, and motivating a diverse talent pipeline that can meet the current and future needs of its businesses.
−Removed: To that end, Abbott provides market competitive compensation, healthcare benefits, pension and/or retirement savings plans, and several programs to facilitate employees building an ownership stake in Abbott, including a global long-term incentive program for employees generally beginning at the manager level.
−Removed: Abbott also has procedures and processes focused on providing employees equitable compensation, regardless of race or gender or other personal characteristics.
+Added: To that end, Abbott provides market competitive compensation, healthcare benefits, continuing education benefits, pension and/or retirement savings plans, financial support for employees with student loan debt, and several programs to facilitate employees building an ownership stake in Abbott, including a global long-term incentive program for employees generally beginning at the manager level.
+Added: Abbott also has procedures and processes focused on ensuring employees receive equitable compensation, regardless of race or gender or other personal characteristics.
The development, manufacture, marketing, sale, promotion, and distribution of Abbott’s products are subject to comprehensive government regulation by the U.S.
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These may require local investment, restrict Abbott’s investments, or limit the import of raw materials and finished products.
−Removed: Abbott’s laboratory facilities and home monitoring services, which provide services, related products and medical devices to consumers, are subject to additional laws and regulations applicable to health care providers and suppliers that submit claims for reimbursement to third-party payors.
+Added: Abbott’s laboratory facilities, home monitoring services,and durable medical equipment suppliers, which provide services, related products and medical devices to consumers, are subject to additional laws and regulations applicable to health care providers and suppliers that submit claims for reimbursement to third-party payors.
In the United States, Medicare, Medicaid, and other third-party payors may from time to time conduct inquiries, claims audits, investigations, and enforcement actions relating to the claims or enrollment criteria.
30 unchanged sentences
The regulation of data privacy and security, and the protection of the confidentiality of certain personal information (including patient health information, financial information and other sensitive personal information), is increasing.
−Removed: For example, the European Union, various other countries, and various U.S.
−Removed: states (e.g., California) have enacted stricter data protection laws that contain enhanced financial penalties for noncompliance.
−Removed: Similarly, the U.S.
+Added: For example, the European Union, China, various other countries, and various U.S.
+Added: states (e.g., California, Virginia, and Colorado) have enacted data protection laws that contain significant compliance obligations and financial penalties for noncompliance.
+Added: In addition, regulators with general consumer protection authority, such as the Federal Trade Commission and U.S.
+Added: states Attorneys General, are focused on how consumer data is used by entities in the health care industry.
+Added: Further, there are regulations of data privacy and security that are specific to health care companies.
+Added: For example, the U.S.
Department of Health and Human Services has issued rules governing the use, disclosure, and security of protected health information, and the FDA has issued further guidance concerning cybersecurity for medical devices.
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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.