PharmaJet announced that its Tropis system is now the exclusive intradermal delivery system for two novel COVID-19 vaccines. Golden, Colorado-based PharmaJet engineers precision delivery systems that overcome the challenges of nucleic acid vaccine delivery. Its Tropis system now offers the delivery of the world’s first plasmid DNA COVID-19 vaccine from Zydus Lifesciences. Exclusively delivered with […]
COVID-19
The top IVD innovation news stories of 2023 — so far
This year is proving to be another important year for innovation in the in vitro diagnostic (IVD) space. According to the FDA, IVD devices are tests performed on samples taken from the human body. They could be everything from blood tests processed in labs to home COVID-19 or pregnancy tests to continuous glucose monitors using […]
Cue Health wins FDA de novo authorization for home COVID-19 test
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 […]
Hologic wins FDA clearance for COVID-flu-RSV assay
Hologic today announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The clearance comes after a winter in which the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV. In February, the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD. “This past winter, we saw […]
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, […]
