Medtech contract manufacturing giant Phillips-Medisize used its human-factors product design expertise to help startup Sotech Health create what the companies claim is a breath sensor system that can detect COVID-19 in less than 30 seconds. Dallas-based Sotech Health has submitted the device to the FDA for an emergency use authorization. It’s also seeking regulatory nods in Canada, […]
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.
Intuitive posts Street-beating Q4 despite COVID-19-related procedure disruptions
Intuitive (Nasdaq: ISRG) shares are down today despite fourth-quarter results that topped the consensus forecast. Despite Street-beating results, the Sunnyvale, California–based robotic surgery technology developer also reported that COVID’s omicron wave is affecting procedure volumes. Intuitive posted profits of $380.6 million, or $1.04 per share, on sales of $1.6 billion for the three months ended […]
Markey wants COVID-19 test-makers to lower prices
Sen. Ed Markey, D-Massachusetts, has sent letters to CEOs of at-home COVID-19 test-makers, asking why tests are selling for as much as $12 apiece. In a letter sent today to Abbott CEO Robert Ford, for example, Markey cited a Reuters story from October 2021 in which British test-maker Mologic said that rapid antigen tests can […]
WHO concludes that updated COVID-19 vaccines may be needed
When confronting an onslaught of new SARS-CoV-2 variants, COVID-19 vaccine makers such as Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have tested tweaked versions of their vaccines but ultimately decided that they were unnecessary. Signs are growing that vaccines developed based on the original strain of the novel coronavirus will struggle to offer durable protection against the omicron […]
Abbott expects COVID testing demand to remain strong, Biden orders insurance coverage
Abbott (NYSE:ABT) Chair & CEO Robert B. Ford has emphasized the importance of COVID-19 testing amid the ongoing omicron variant surge. Today at the 40th Annual J.P. Morgan Healthcare Conference, Ford highlighted the role testing will play as Abbott’s BinaxNow rapid antigen test and other over-the-counter testing options remain in high demand. The need for […]
FDA postpones some inspectional activities amid omicron surge
The FDA announced earlier this week that it made some temporary changes to its inspectional activities due to COVID-19. With the omicron variant of the virus causing surges across the world, the FDA implemented the changes in the U.S. on Dec. 29, 2021, to ensure the safety of its employees and the firms it regulates, […]
BD at-home COVID tests are heading to Southeast grocery stores
BD recently announced that it has partnered with Southeaster Grocers and Everly Health to distribute its at-home COVID-19 tests in grocery stores. Through the partnerships, Everly Health will distribute the BD Veritor at-home COVID-19 tests to Southeastern Grocers’ Fresco y Más, Harveys Supermarket and Winn-Dixie stores in the southeastern U.S. Veritor at-home COVID-19 tests are […]
FDA issues draft guidance for transitioning medical devices granted EUAs during pandemic
The FDA is proposing that it give medical device makers about half a year’s notice before terminating emergency use authorizations post-pandemic. That was one of the major takeaways from the draft guidance that the FDA released today. It considers ways to transition medical device regulation once COVID-19 moves from a pandemic to an endemic phase. […]
The pandemic tested Medtronic’s mettle: Its CFO explains how
CFO Karen Parkhill discusses leadership, innovation and restructuring Medtronic — the largest organization in medtech. Karen Parkhill drew on her experience in the banking industry to offer Medtronic a prognosis as the COVID-19 pandemic started rippling across the globe. Parkhill, Medtronic’s CFO and EVP, was CFO of JPMorgan Chase’s commercial banking business during and after the […]
Biden announces plans to buy, distribute 500M at-home, rapid COVID-19 tests
The White House today announced a COVID-19 response plan that includes a major effort to increase at-home rapid testing. President Joe Biden’s plan includes opening new federal testing sites to increase capacity and the distribution of 500 million at-home, rapid tests to Americans. The Biden administration plans to purchase a half-billion rapid tests this winter […]
BD acquires digital at-home test maker Scanwell Health
BD (NYSE:BDX) announced today that it completed the acquisition of smartphone-enabled, at-home medical test developer Scanwell Health. Financial terms for the transaction were not disclosed. BD expects the acquisition to be immaterial to its fiscal 2022 results, with Scanwell’s financial results reported under BD’s integrated diagnostic solutions business within the life sciences segment. Franklin Lakes, […]
