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Member Company Response Effort

Since the onset of the coronavirus (COVID-19) outbreak, AdvaMed member companies have donated millions of dollars’ worth of medical products and cash to hospitals, foundations and charities around the world. Medical device companies are responding to increased demand by ramping up production wherever possible, coordinating closely with governments to ensure the delivery of supplies where they are most needed, and in some cases, creating new devices and diagnostic tests to help effectively diagnose and treat sick patients.

Below is a collection of some of the efforts undertaken recently by AdvaMed member companies based on public statements.

View a list of companies that have developed IVDs that have received Emergency Use Authorization from the U.S. Food and Drug Administration.

3M announced in a press release on July 14 that the company has partnered with researchers from the Massachusetts Institute of Technology (MIT) to develop a rapid point-of-care COVID-19 antigen test. This viral antigen test would provide results within minutes via a paper-based device while at the point-of-care, and would not require samples to be sent to laboratories. Read more here.

In May, 3M was awarded two contracts with the U.S. Department of Defense to nearly triple production of N95 respirator masks for the U.S. by October 2020 – totaling about 95 million per month versus 35 million per month. See the company’s statement here. In March, 3M announced expectations to be producing the U.S. respirators at a rate of 50 million per month by June, a 40 percent increase, and plans to double global capacity to reach 2 billion-per-year within 12 months. 3M began the year in January by doubling global output to a rate of 1.1 billion per year, or 100 million per month. Read more here.

Abbott received Emergency Use Authorization (EUA) from FDA March 18 for its first molecular test for COVID-19, used on its m2000 RealTime system (see more here), followed by an EUA March 27 for its ID NOW rapid molecular COVID-19 point-of-care test that delivers results in as little as five minutes (see more here). On April 15, the firm also announced launch of a lab-based serology test for COVID-19 antibodies. Abbott plans to file an EUA submission for the latter test, which is initially being made available under FDA’s notification policy for diagnostic tests for COVID-19 during the public health emergency. Read more.

Abiomed’s Impella RP temporary heart pump gained FDA Emergency Use Authorization for an expanded indication to treat COVID-19 related acute right heart failure or decompensation, including pulmonary embolism, the company announced June 1. The minimally invasive circulatory support device was approved by FDA in 2017 to treat right ventricular failure in the setting of acute myocardial infarction and after cardiac surgery. “For critically ill patients the Impella RP can be rapidly deployed in a matter of minutes using a minimally invasive technique in the cardiac catheterization laboratory or operating room,” the company explains. Read the press release here.

AdviNOW Medical announced on June 9, 2020 that the company has introduced a way for full medical exams for patients to be performed remotely in the midst of COVID-19 using Artificial Intelligence (AI). The AI technology goes beyond video calls between healthcare providers and patients and allows medical measurements to be performed while documenting the entire visit for healthcare providers. The company suggests that this will allow healthcare providers to treat more patients, at up to four more per hour. Read more here.

Baxter is committed to working with global partners to ramp up production of PPE for health care providers, patients, and their employees, the company reported April 2. The company has also committed resources to relief organizations helping to promote telemedicine opportunities and mobilize critical supplies, among other activities, and is matching employee donations to selected nonprofit partners by 2:1. Read more here.

Bayer is donating funds to Spain for hospital beds and medical equipment to fight the corona pandemic, as well as testing equipment. The donation is worth an aggregate of about 1M euros, the firm announced April 8. Read more here. The package is one of numerous Bayer efforts worldwide. The firm is also supporting hospitals in Lombardy, Italy, with a donation of 1M euros, the firm announced March 18. The funds will support regional authorities in procurement of equipment for intensive care units in hospitals with the greatest needs. Read more. Earlier this year, the firm sent financial and material support to China valued at about EUR 1.5M to help contain the pandemic. View the press release.

B. Braun Medical announced April 13, 2020, it received FDA emergency use authorization (EUA) for use of infusion pumps with nebulizers to treat COVID-19 patients. The alternative treatment will allow continuous medication to be delivered into a nebulizer for critically ill COVID-19 patients while decreasing exposure to health care providers. Read the press release

BD received FDA Emergency Use Authorization (EUA) July 2 for its portable, rapid, point-of-care antigen test for COVID-19, which is run on BD’s widely available Veritor Plus System. BD notes the instrument is currently in use at more than 25,000 hospitals, clinician offices, urgent care centers and retail pharmacies in all 50 U.S. states. Only the second commercial antigen test to receive EUA authorization, the immunoassay delivers results within 15 minutes. BD expects to ramp up production to 2 million tests per week by the end of September. Read the press release here.

BD announced April 3 receipt of an EUA for the BioGx COVID-19 molecular diagnostic test, which returns results in under three hours using the BD MAX automated molecular diagnostic platform. The platform is in use at hundreds of labs in nearly every U.S. state, with each unit capable of analyzing hundreds of samples per day, according to the company. Read the press release here. BD also gained an EUA April 8 for an additional molecular diagnostic test for COVID-19 on the BD MAX system, and which returns results in two to three hours. See the press release here. Separately, BD and BioMedomics announced in March the launch of point-of-care rapid serology antibody test that provides results in as little as 15 minutes. Read the press release here.

Boston Scientific has donated more than $2M in supplies to hospitals, including PPE, to meet urgent needs of health care providers, according to the company. In addition, Boston Scientific is collaborating with the University of Minnesota Bakken Medical Device Center on a ventilator alternative to replace manual respiration in emergency settings by using a robot to pump an Ambu® bag. The firm is also collaborating with the University of Minnesota to develop a reusable personal respirator and PPE. Read more.

BioMérieux BioFire RP2.1 panel molecular test for COVID-19 received FDA emergency use authorization May 1. It can detect 22 respiratory infection pathogens in one test. The firm’s first COVID-19 molecular test gained EUA in March. Read more hereand here.

Bio-Rad Laboratories received FDA emergency use authorization (EUA) April 29 for a COVID-19 total antibody serology test that detects all three antibodies (IgM, IgA, IgG) to the disease. The test features diagnostic specificity of more than 99% and sensitivity of 98%, according to the company. Read more here.

C2Dx debuted April 30 its Aero|Guard Personal Protection Barrier as a form of personal protective equipment. The barrier device is designed to provide added protection to health care personnel when they perform patient intubation and extubation processes in the OR, ICU and ER, the company explains. Read more here.

Cardinal Health is collaborating with suppliers to increase product supply, and partnering closely with trade groups including AdvaMed, the Health Industry Distributors Association, Healthcare Distribution Alliance, National Community Pharmacists Association, National Association of Chain Drug Stores, and Healthcare Ready to respond to industry-wide challenges. Read more

Cepheid’s Xpert® Xpress SARS-CoV-2 rapid molecular diagnostic for COVID-19 became the first commercially available point-of-care test for the disease upon receipt of an EUA from FDA, announced March 21. The test is run on Cepheid's installed base of over 23,000 automated GeneXpert® Systems worldwide, with a detection time of approximately 45 minutes. Read the press release.

Cook Medical has responded to the COVID-19 pandemic by increasing manufacturing levels up to 25% to address unprecedented demand for critical care products including airway management devices used in ICUs where COVID-19 patients are treated, the company reported April 30. The firm notes it has also donated personal protective equipment to health care providers on the frontlines of the pandemic, and provided hand sanitizer for local communities. Read more here.

Danaher CorporationFive Danaher operating companies donated RMB 10 million ($1.4M) of diagnostic equipment, reagents and other products to hospitals in Wuhan, China to combat COVID-19. Included in the donation is: Beckman Coulter Diagnostics' hematology analyzers, Beckman Coulter Life Sciences' flow cytometers, Radiometer's blood gas analyzers, Cepheid's Xpert® Xpress Flu/RSV assay, and Hach's UV-Vis spectrometers.

Exthera Medical's Seraph®100 Microbind® Affinity Blood Filter has received FDA Emergency Use Authorization (EUA) for treating COVID-19, the firm reported April 17, 2020. The blood purification therapy binds and removes SARS-CoV-2 virus/RNA while improving vital signs and laboratory parameters associated with inflammation and tissue damage, the company explains. Read more. The device received a European CE Mark in 2019 for reduction of pathogens in blood, and is widely available in Europe. Read more.

GE Healthcare CEO Kieran Murphy shared on March 6 that the company is accelerating manufacturing, with plans to rapidly deliver around 1,000 pieces of technology, such as CTs, ultrasounds, monitors and ventilators, among several other response efforts. Read more. GE Healthcare announced March 24 that since the COVID-19 outbreak began, the company has doubled its capacity of ventilator production and has plans to double it again by mid-year to address unprecedented demand — independent of its recent collaboration with Ford to scale up supplies of the devices. Read more. 

Haemonetics has made charitable contributions to the Massachusetts COVID-19 Relief Fund and Direct Relief in support of COVID-19 pandemic response efforts. The company has also donated PPE to the Massachusetts Emergency Management Agency. Haemonetics continues to provide its technologies to a variety of organizations to help create collection capacity for convalescent plasma and to aid research on COVID-19-associated coagulopathy. Additionally, Haemonetics is supporting its medically qualified employees choosing to volunteer as supplemental staff in healthcare or emergency service settings. Read more.

Hologic created a fully automated test that detects genetic material from SARS-CoV-2, the new coronavirus strain, in under three hours. The test recently was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). Read more.

Johnson & Johnson has earmarked $50M for COVID-19 response efforts, primarily focused on supporting frontline health workers. This includes product donations in China, Italy, South Korea, and more, with over $3.7M in personal protective equipment like goggles, protective suits and masks. J&J is also working diligently to convert manufacturing lines at several facilities around the world to produce hand sanitizer in accordance to FDA and CDC guidelines as quickly as possible that will help protect R&D, manufacturing and distribution employees, and to be donated to health and community service workers on the front lines of care. Read more. Additionally, J&J is working with partners to develop a vaccine. Read more here and here

The Lilly Foundation contributed $500,000 to United Way of Central Indiana’s Community Economic Relief Fund. The fund will support human services organizations and the individuals and families they serve who are affected directly or indirectly by the COVID-19 virus. The Lilly Foundation is also providing a 2:1 match for Lilly employee and retiree contributions to the fund.

Lilly and AbCellera agreed to co-develop antibody products for the treatment and prevention of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus. The collaboration will leverage AbCellera's rapid pandemic response platform and Lilly's global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies. Read more.

Medtronic continues to make progress in increasing ventilator production worldwide. As of March 18, the company reported having increased production over 40 percent, and being on-track to more than double its capacity to manufacture and supply ventilators in response to COVID-19. Read more. The firm’s partnership with Baylis Medical, a Canadian-based device company, will also help produce ventilators for hospitals in Canada, Baylis announced April 7. Read the press release. 

Olympus installed endoscope systems into the Wuhan Huo Shen Shan Hospital within 10 days to treat infected patients. In addition to monetary donations to the Red Cross Society of China Huanggang, Olympus has donated 15 sets of laryngoscopes to the China Social Welfare Foundation, and 25 biological microscopes to the Chinese Center for Disease Control and Prevention, totaling approximately $500,000 in donations.

OraSure Technologies is developing a rapid, oral fluid, pan-SARS-coronavirus antigen test for in-home self-testing under a $710M contract from HHS’s Biomedical Advanced Research and Development Authority (BARDA), the company announced in an April 6 press release. The test will be based on the firm’s OraQuick platform, currently used to test for diseases such as HIV in 20 minutes. OraSure anticipates development in 4-6 months, prior to seeking FDA Emergency Use Authorization (EUA).

Ortho Clinical Diagnostics received FDA Emergency Use Authorization for its second serology antibody test for COVID-19 on April 24. The COVID-19 IgG antibody test is similar to Ortho's COVID-19 total antibody test, which received EUA on April 14, and both have demonstrated 100% specificity, according to the company. The tests are run on Ortho's high-throughput, automated VITROS platforms, already installed in more than 1,000 hospitals and labs across the U.S., and will facilitate decisions about the propriety of a patient returning to work, Ortho notes. The firm plans to manufacture several million COVID-19 antibody tests each month. Read more here and here.

PMT Partners announced April 13 that its small, compact, and portable Oxylator® ventilation-resuscitation device was successfully used to treat a patient with COVID-19. Read more. Earlier this year, the firm said it had 1,000 emergency ventilation-resuscitation devices available for hospitals and emergency medical services.

QIAGEN received FDA Emergency Use Authorization (EUA) for its QIAstat-Dx Respiratory SARS-CoV-2 Panel test, the firm announced March 31. The test can differentiate COVID-19 from 20 other serious respiratory infections and a provide a result in “about one hour,” according to the company. Read more

Quidel's Sofia is the first COVID-19 antigen test to gain FDA Emergency Use Authorization (EUA), the firm announced May 8. The point-of-care test uses nasal or nasopharyngeal specimens, and provides results in 15 minutes to accelerate time to diagnosis. Read morehere. The firm’s Lyra RT-PCR molecular assay for COVID-19 received EUA on March 17. Read more. The company subsequently had received an expanded EUA for use of the Lyra test on additional platforms and with expanded specimen types, as well as CE Mark approval and Health Canada authorization for marketing overseas, the firm announced March 25. Read more here

ResMed CEO Mick Farrell stated March 23 that over 7,500 ResMed employees are working diligently in over 140 countries with government officials and health care workers to maximize production and delivery of essential ventilators and other respiratory support devices. The company is looking to double or triple ventilator output, and scale up ventilation mask production by tenfold. Read more.  Earlier this year, the firm reported sending over 100 ventilators from its facility near Shanghai to Wuhan, with plans to send hundreds more and thousands of masks. Read more.

Roche's Elecsys COVID-19 serology antibody test received FDA emergency use authorization May 2, featuring specificity greater than 99.8% and sensitivity of 100%, according to the company. Roche will ramp up production capacity to the “high double-digit millions per month,” the firm says. Read more here.

S3 Connected Health’s CE-marked, web-based clinical support tool is being rolled out to hospitals across the Irish health care system to aid health care workers in triaging COVID-19 patients and optimizing and scaling acute respiratory care, the company announced May 7. The ACORRD – Assessment of COVID-19 Risk of Respiratory Deterioration – app can be used on clinician’s smartphones, according to the company. Read more here.

Siemens Healthineers obtained the first FDA Emergency Use Authorization (EUA) for a semi-quantitative COVID-19 antibody test on July 31. The serology test – which offers 100% sensitivity and 99.9% specificity – shows the estimated quantity of SARS-CoV-2 IgG antibodies. The EUA bolsters Siemens’ existing COVID-19 test line and is the company’s fifth antibody test to receive EUA with sensitivity and specificity greater than 99 percent. Read more here. Siemens’ test portfolio for COVID-19 also includes a molecular diagnostic test kit for the disease, which received EUA authorization in May (read more here), as well as blood gas and other tests to aid in the care of acute infected patients. In March, the firm announced FDA clearance for its RAPIDPoint® 500e Blood Gas Analyzer critical care testing solution. Read more here. Separately, the firm announced April 16 that the Siemens Foundation is providing $1.5M to community health centers across 12 U.S. cities to respond to COVID-19. Read more here.

Smith+Nephew has been working to support its employees and customers in China. They are liaising closely with the local authorities, supporting urgent cases and donating product, in particular from their Advanced Wound Care range, and cash via the Red Cross, in aggregate worth approximately $250,000. Chief Executive Officer, Roland Diggelmann, shared the following statement, “Smith+Nephew has been responding to the COVID-19 outbreak for many weeks, first in China, and now in countries across the world. Our focus is to protect the health and well-being of our employees while continuing to serve customers. The commitment of our employees has ensured we have kept our products and services flowing. We stand together ready to offer assistance during this unprecedented and challenging period.” Read more.

STERIS has received Emergency Use Authorization (EUA) from FDA to decontaminate N95 or N95-equivalent respirators up to 10 times using the Non-Lumen Cycle of the V-PRO® Low Temperature Sterilization System. Read more here.

Stryker released a statement on April 6, 2020 that the company has increased production of hygiene, disinfecting and surgical protection products, as well as hospital beds, stretchers, and defibrillators. This shift in manufacturing priorities reflects the company’s global dedication to helping customers so they can focus on taking care of patients.

Additionally, Stryker has developed a low-cost, limited-release emergency response bed to quickly aid healthcare providers with efficient care during the COVID-19 pandemic. They are also exploring the viability of decontaminating N95 respirator masks for emergency use in healthcare settings through their expertise in sustainable solutions. Read more.

Terumo BCT announced April 10, 2020, its receipt of an EUA from FDA for use of its Spectra Optia Apheresis System combined with Marker Therapeutics’s D2000 Adsorption Cartridge to reduce pro-inflammatory cytokine levels in adult ICU patients with COVID-19 in cases of confirmed or imminent respiratory failure. The devices work together to filter cytokines from a patient's blood. Read the press release.

Varian has donated 1 million RMB to the China Red Cross. View the press release.

Vyaire Medical has been awarded a $407M contract by HHS to produce 22,000 ventilators by the end of June, the company announced April 16. The lightweight, portable LTV2 2200 ventilators have received FDA Emergency Use Authorization to enable rapid U.S. deployment while the company pursues 510(k) clearance. The HHS contract “allows us to further dramatically expand our production capabilities to help satisfy the intensifying need for respiratory care equipment,” the company said. Read more here.