Abbott (NYSE:ABT) has launched another defense of its ID NOW rapid COVID-19 diagnostic test, this time with interim clinical trial results that confirm assertions the company made in May. A total of 1,003 people were evaluated in urgent care clinics, hospitals and nursing homes, where Abbott said ID NOW delivered the following results compared with those […]
FDA defies Trump on vaccine approval timeline
The FDA today told COVID-19 vaccine developers that it needs two months’ worth of safety data before it will consider emergency approvals. The agency’s move cast further doubt on a vaccine against SARS-COV-2 being ready by election day, November 3 — a notion mentioned repeatedly by President Trump in attempts to pressure the agency to […]
BD’s automated flow cytometry system wins FDA clearance
Becton Dickinson (NYSE:BDX) today announced it has received 510(k) clearance from the FDA for its FACSLyric flow cytometer with the integrated BD FACSDuet sample preparation system. The system enables clinical laboratories to fully automate the sample-to-answer process and improve their efficiency by reducing errors and limiting the manual user interactions required to run assays on the […]
AdvaMed pushes for Medicare coverage of digital health tech
Medtech trade group AdvaMed today called on the federal government to expand Medicare coverage to digital health technologies. The Medicare statute does not directly address coverage of digital health technologies, nor does it specifically limit or prohibit their coverage. But it doesn’t make Medicare coverage easy, either. Get the full story on our sister site, […]
CDC: Ethylene oxide may have more health effects than cancer
The Centers for Disease Control and Prevention yesterday released a draft toxicity profile of ethylene oxide (EtO) that treats it as a more far-reaching health threat than the Environmental Protection Agency does. The EPA and the federal Department of Health and Human Services both consider EtO a human carcinogen. The medical device industry relies on […]
Feds target Medtronic in ventilator antitrust investigation
Medtronic (NYSE:MDT) is under investigation by the federal government for allegedly limiting competition in the ventilator business, the company acknowledged late yesterday. The civil antitrust probe grew out of complaints about device shortages during the coronavirus pandemic, according to a report by the Wall Street Journal. The Journal cited “people familiar with the matter” as saying […]
Surgical Innovation Associates gains CE Mark for absorbable mesh
Surgical Innovation Associates announced this week that it has secured CE Mark approval for its flagship absorbable mesh, DuraSorb. The product is designed to provide mechanical support and scaffolding during the early months of wound healing and scar formation, followed by gradual absorption to leave the patient free of foreign material by one year, according to […]
Federal rule on ethylene oxide now delayed until 2021
The final federal rule limiting ethylene oxide (EtO) emissions from commercial medtech sterilization plants is now set to come out in 2021, according to the Environmental Protection Agency. Before the COVID-19 pandemic struck, the EPA had expected to issue the rule in May 2020. The agency considers ethylene oxide a carcinogen, and EtO emissions have attracted national […]
AdvaMed launches campaign against ‘misleading’ legal advertising
Medtech trade group AdvaMed this week debuted a website that tracks law firm TV advertisements aimed at patients who have had certain medical devices implanted. The “Responsible Advertising for Patient Safety” site says that such ads mislead patients into legal action against the manufacturers of devices that are “non-faulty” and may jeopardize patient safety. Get the full […]
What are the top COVID-19 vaccine candidates?
As of yesterday, five COVID-19 vaccine candidates had begun Phase 3 clinical trials as they seek to determine the safety and efficacy of their formulas. Researchers worldwide are testing 132 COVID-19 vaccine candidates, including 42 that are in clinical trials on humans and at least 92 in preclinical or animal trials, according to the New […]
Novavax launches Phase 3 COVID-19 vaccine trial in UK
Novavax (NSDQ:NVAX) today announced that it has begun its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of its COVID-19 vaccine candidate, NVX-CoV2373. The trial is underway in the UK, in partnership with the UK government’s Vaccines Taskforce. Gaithersburg, Md.-based Novavax said it expects to enroll up to 10,000 individuals between 18 and […]