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coronavirus

Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.

Medtronic responds to NY Times story about failed ventilator contract

March 30, 2020 By Sean Whooley

Medtronic (NYSE:MDT) is providing additional facts in response to a New York Times report detailing an acquisition by Covidien that allegedly changed the course of a government contract designed to increase ventilator supply, now a major problem amid the coronavirus pandemic. Medtronic bought Covidien for $50 billion in 2015 — years after the events described in the […]

Filed Under: Business/Financial News, Contract Manufacturing, Featured, Food & Drug Administration (FDA), Mergers & Acquisitions, Regulatory/Compliance, Respiratory Tagged With: coronavirus, COVID-19, Covidien, FDA, Medtronic, Newport Medical Instruments

Medtronic launches COVID-19 monitoring system

March 30, 2020 By Sean Whooley

Medtronic Care Management Services is launching two new software programs for assessing, monitoring and triaging people concerned about COVID-19 and potential symptoms. The MCMS COVID-19 virtual care evaluation and monitoring system — which Medtronic (NYSE:MDT) announced late last week —  is now available to U.S. health systems, plans and employers. It follows the company’s launch of […]

Filed Under: Digital Health, Featured, Health Technology, Patient Monitoring, Respiratory, Software / IT Tagged With: coronavirus, COVID-19, Medtronic, provationmedical

Could respirator decontamination solve shortage problems?

March 29, 2020 By Danielle Kirsh

The FDA has issued an emergency use authorization for the Battelle Critical Care Decontamination System, which can decontaminate tens of thousands of respirator masks per day so that health personnel can reuse them. The Columbus, Ohio-based nonprofit tech development company announced on March 28 that it began rapid manufacturing of its system to decontaminate N95 […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Regulatory/Compliance, Respiratory, Sterilization / Calibration Tagged With: Battelle, coronavirus, COVID-19

Medline reopens Illinois medtech sterilization plant

March 28, 2020 By Nancy Crotti

Medline Industries resumed sterilization operations at its Waukegan, Ill., plant on Friday, following state certification of the company’s $10 million in emission-control upgrades, the company announced. The Waukegan plant reopening follows the decision this week by officials in Cobb County, Ga., to allow an Atlanta Sterigenics EtO plant to reopen for 21 days to sterilize devices and products […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance, Sterilization / Calibration Tagged With: coronavirus, ethylene oxide, Illinois Environmental Protection Agency, Medline Industries Inc.

Cohealo to enhance ventilator sharing network

March 27, 2020 By Sean Whooley

Cohealo announced today that it intends to add customers to its national ventilator sharing network to help health systems monitor capacity and mobilize ventilators to hospitals that need them most. The Boston-based company’s effort is in response to a shortage of ventilators as a result of the COVID-19 pandemic. Several companies have taken it upon […]

Filed Under: Business/Financial News, Featured, Health Information Technology, Health Technology, Respiratory, Software / IT Tagged With: Cohealo, coronavirus, COVID-19

Trump orders GM to make ventilators

March 27, 2020 By Danielle Kirsh

After a deal between General Motors and Ventec Life Systems to produce 80,000 ventilators briefly appeared halted, President Trump yesterday ordered GM to proceed under the Defense Production Act. A New York Times report earlier on Friday said the Federal Emergency Management Agency had paused the $1 billion plan, saying it needed time to determine […]

Filed Under: Business/Financial News, Featured, Hospital Care, Respiratory Tagged With: coronavirus, COVID-19, Donald Trump, General Motors, Ventec Life Systems

AdvaMed: Invoking Defense Production Act could hinder U.S. medtech imports

March 27, 2020 By Nancy Crotti

Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply of those items, the head of medtech trade group AdvaMed said today. AdvaMed officials have talked with U.S. secretary of Health and Human Services Alex Azar and FDA commissioner Dr. Stephen Hahn about medtech […]

Filed Under: Business/Financial News, Contract Manufacturing, Diagnostics, Distribution, Featured, Food & Drug Administration (FDA), Hospital Care, Regulatory/Compliance, Respiratory Tagged With: 3m, AdvaMed, coronavirus, FDA, GE Healthcare, General Motors, Global Medical Technology Alliance, Medtronic, U.S. Department of Health and Human Services, Ventec Life Systems, Zoll Medical

GE Healthcare quadruples ventilator production at Wisconsin plant

March 27, 2020 By Sean Whooley

General Electric Healthcare (NYSE:GE) this week announced that it is  doubling its production capacity for ventilators and expanding its Madison, Wisconsin, production line to 24-hour operation. In a report on GE’s website, the company shared that it has doubled its capacity of ventilator production with plans to double it again by the end of the second […]

Filed Under: Business/Financial News, Featured, Respiratory Tagged With: coronavirus, COVID-19, Ford, GE Healthcare

DeviceTalks Weekly: Ep. 3 – Deconstructing medtech’s alphabet soup – DPA, MDR, FDA are all in the news

March 27, 2020 By Tom Salemi

In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less […]

Filed Under: Business/Financial News, Contract Manufacturing, Device Talks Podcasts, Featured, Legal News, Regulatory/Compliance, Respiratory Tagged With: coronavirus, COVID-19, DeviceTalks Weekly, EU MDR, Fang Consulting, FDA, Hogan Lovells

Thermo Fisher Scientific wins CE mark for COVID-19 test

March 27, 2020 By Sean Whooley

Thermo Fisher Scientific (NYSE:TMO) announced that it received CE Mark approval in Europe for the use of its diagnostic test in detecting nucleic acid from the SARS-CoV-2 virus that causes COVID-19. The Waltham, Mass.-based company’s test uses Applied Biosystems’ TaqPath assay and real-time PCR technology. It is designed to provide results within four hours of a […]

Filed Under: Diagnostics, Regulatory/Compliance Tagged With: CE Mark, coronavirus, COVID-19, FDA, Thermo Fisher Scientific

Medtronic Foundation pledges $10m to COVID-19 efforts

March 26, 2020 By Sean Whooley

Medtronic (NYSE:MDT) announced that its Medtronic Foundation is making an additional $10 million in contributions to COVID-19 relief efforts around the world. The Fridley, Minn.-based company said in a news release that the funds will be put toward training and supervising frontline health workers, ensuring their safety (including the provision of personal protective equipment and other […]

Filed Under: Business/Financial News Tagged With: coronavirus, COVID-19, Medtronic

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