Cue Health (Nasdaq:HLTH) announced that it received FDA de novo authorization for its Cue COVID-19 molecular test. San Diego-based Cue Health designed the test for both home and point-of-care use. Its authorization marks the first such nod for a home-use COVID-19 test, the company said. It also represents the first de novo authorization for any […]
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.
How the BD diagnostics business is driving greater access to care
It’s been a busy time for BD, with recent approvals further driving the company’s diagnostics business forward. Dave Hickey and BD (NYSE:BDX) have their sights on what they call “transformative forces.” These forces could change the delivery of healthcare going forward. Hickey, EVP and president of the Life Sciences segment at BD, said these forces […]
FDA extends shelf life of some popular COVID tests
The FDA announced today that certain COVID-19 diagnostic tests under emergency use authorization now have a longer shelf life. Diagnostics made by Abbott, Maxim Biomedical and iHealth Labs all received extensions for their expiration dates. The Abbott BinaxNow COVID-19 antigen self-tests now have a shelf life of 22 months. Previously, the popular test had a […]
LivaNova LifeSparc ACS pump cleared for extended use
LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use its LifeSparc advanced circulatory support (ACS) pump for extracorporeal membrane oxygenation (ECMO). The new clearance makes permanent some of the temporary emergency guidelines under which LifeSparc provided ECMO therapy during the height of the COVID-19 pandemic. In a news release posted […]
Bio-Rad stock dips as COVID-19-related sales taper off in Q3
Bio-Rad (NYSE:BIO) shares took a hit on third-quarter results that came in mixed compared to the consensus forecast. BIO shares were down more than 6% at $359.75 apiece this morning — a day after the company released its results. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down […]
Vaxxas receives more than $5 million grant for vaccine delivery patch
Vaxxas announced today the Australian government is granting it nearly $5.5 million for the manufacturing of its vaccine delivery device. Cambridge, Massachusetts-based Vaxxas picked up AU$8.2 million ($5.48 million). The second-round grant represents part of the Australian government’s Modern Manufacturing Initiative (MMI). Funding supports the manufacturing scale-up of Vaxxas’ device for applying vaccines to the […]
Medtech executive convicted of COVID-19 tests fraud
A federal jury convicted the president of a medtech company — Arrayit — accused of participating in a scheme to mislead investors over COVID-19 tests. In June 2020, the U.S. Department of Justice (DOJ) charged Arrayit president March Schena for alleged involvement with fraudulent claims for allergy and COVID-19 testing. The charges alleged a scheme […]
Henry Schein misses on Q2 sales amid declining demand for COVID-19 tests
Henry Schein (Nasdaq:HSIC) shares are down today on second-quarter sales that missed the Wall Street consensus forecast amid declining COVID-19 test demand and foreign exchange headwinds. The Melville, New York–based company posted profits of $160 million, or $1.16 per share, on sales of just over $3 billion for the three months ended June 25, 2022, […]
FDA re-authorizes Meridian Bioscience’s COVID-19 assay
Meridian Bioscience (Nasdaq:VIVO) announced today that the FDA re-authorized the emergency use authorization (EUA) for its COVID-19 test. Cincinnati-based Meridian received EUA from the FDA on Nov. 10, 2021, for its Revogene SARS-CoV-2 assay. Following authorization, it was determined that the original design of the assay would not detect the Omicron variant, leading Meridian to […]
Masimo’s SafetyNet monitoring reduced length of COVID-19 hospital stays, study says
Masimo (Nasdaq:MASI) announced that a two-part retrospective study demonstrated the impact of its SafetyNet monitoring system. Irvine, California-based Masimo’s study, led by Dr. Hemali Patel and colleagues at the University of Colorado and UC Health (UCH) in Aurora, Colorado, evaluated the impact of remote patient monitoring of COVID-19 patients using SafetyNet on hospital length of […]
BD launches combination COVID-19, flu, RSV diagnostic test
BD (NYSE:BDX) today announced it has launched a new molecular diagnostic combination test for SARS-CoV-2, influenza A and B and respiratory syncytial virus (RSV) following CE mark approval. The BD Max test uses a single nasal swab or nasopharyngeal swab sample to determine if a patient has COVID-19, the flu or RSV. Franklin Lakes, N.J.-based […]
