New Medtronic (NYSE:MDT) CEO Geoff Martha openly disagreed yesterday with President Donald Trump’s mission to bring formerly U.S.-based companies back to this country, according to a report in the Irish Times. Medtronic, which maintains a U.S. headquarters in Fridley, Minn., bought Dublin-based Covidien for $50 billion in 2015 and moved its global headquarters to Ireland in […]
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.
FDA eases regs on certain device changes during pandemic
The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do not create […]
Abbott: ID NOW COVID-19 results more accurate with earlier testing
Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms. The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization […]
This wearable could help people practice safe distancing amid COVID-19
Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic. As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other. […]
Abbott to supply millions of its COVID-19 antibody tests to U.K. government
Abbott (NYSE:ABT) will supply millions of its laboratory-based COVID-19 antibody tests to the U.K.’s National Health Service over the coming months under a contract announced today. The company has already shipped 800,000 of the IgG antibody test to NHS laboratories this week. The news comes on the same day that Abbott said that Health Canada has […]
NFL looking at modified facemasks for helmets
NFL Players Association medical director Thom Mayer told ESPN that the league is developing facemasks to protect players from COVID-19. Speaking to ESPN reporter Adam Schefter on The Adam Schefter Podcast, Mayer said the league and Oakley are testing prototypes of helmets with a modified facemask that could contain surgical material or even the material […]
Health Canada authorizes Abbott COVID-19 antibody test
Abbott (NYSE:ABT) announced today that Health Canada has granted interim authorization for its Architect SARS-CoV-2 IgG serology test for COVID-19. The Abbott Park, Ill.-based company won an FDA emergency use authorization and the CE Mark for the same antibody test for use on its Architect system in April. The test is designed to detect the IgG […]
Medtronic misses mark in Q4 as sales decline 26%
Medtronic (NYSE:MDT) announced fourth-quarter results today that were even worse than expected, but the world’s largest medical device company is still upping its dividend and investing in future growth. The Fridley, Minn.–based medtech giant reported profits of $646 million, or $0.48 per share, on sales of $6.0 billion for the three months ended April 24, 2020, […]
This patient-mover got an emergency COVID-19 nod from the FDA
AR Tech, a division of A&R Tarpaulins, announced today that the FDA has granted an EUA for its Patient Isolation Transportation Unit (PITU) to help hospitals better manage the COVID-19 pandemic. “PITU is a game-changer in this fight against the pandemic because it is a negative pressure isolation enclosure that makes working with highly contagious […]
FDA approves Phase 3 trial for coronavirus drug
Octapharma announced today that the FDA approved its investigational new drug (IND) application for a Phase 3 clinical trial for its drug therapy in COVID-19 patients. Octagam 10% [Immune Globulin Intravenous (Human)] therapy will be observed for efficacy and safety in use with COVID-19 patients with severe disease progression, according to a news release. Get the […]
G Medical Innovations ECG Patch receives FDA EUA for use in COVID-19 patients
G Medical Innovations recently announced that it received FDA emergency use authorization for its vital signs monitoring system ECG patch for remote monitoring of patients who are being treated for COVID-19. The patch monitors the QT interval of an ECG in patients to watch for fatal arrhythmias that may occur from treatment drugs. Prolonged QT […]
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