Becton Dickinson (NYSE:BDX) announced today that it received CE Mark approval in Europe for its rapid COVID-19 test. Franklin Lakes, N.J.-based BD’s rapid, point-of-care SARS-CoV-2 antigen test — used on the BD Veritor Plus system — delivers results in 15 minutes on a portable instrument to allow for on-site results and decision making, according to a […]
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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 […]
BD is paying $60M to settle Bard pelvic mesh suits with most U.S. states
Becton Dickinson (NYSE:BDX) will pay $60 million to 48 U.S. states to resolve allegations that its C.R. Bard business deceptively marketed transvaginal surgical mesh devices, state attorneys general in California and Washington announced today. Mesh products were meant to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs, but they instead sparked […]
BD has another Class I infusion device recall
The FDA issued another Class I recall designation for the BD Alaris from Becton Dickinson (NYSE:BDX), this time for potentially incorrect displays. Recalled products include the BD Alaris syringe module (model 8110) and BD Alaris PCA module (model 8120), and the BD Alaris syringe/PCA sizer sensor replacement kit (P/N 122786). Affected products related to the infusion […]
Feds unveil COVID-19 vaccine distribution plan
The Trump administration today released a plan to distribute an eventual COVID-19 vaccine free of charge, initially to targeted groups and more broadly as supply increases. The government is planning a phased distribution using a contract awarded to McKesson in August. The first recipients could include: Healthcare personnel likely to be exposed to or treat […]
Report: BD investigating false-positive COVID-19 test results
Reports today say that Becton Dickinson (NYSE:BDX) is investigating false-positive results from its COVID-19 tests in nursing homes. The Wall Street Journal reported this morning that the company is probing reports of false positives from assays analyzed through its handheld, point-of-care Veritor Plus system. A Becton Dickinson spokesperson confirmed that the company is aware that a […]
BD has a serious recall of some Alaris System infusion pumps with stuck keys
The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris PC unit is Class I, the most serious kind. Initiated on Aug. 4, 2020, the recall pertains to the BD Alaris PC unit 8015 and five affected keypad replacement kits manufactured between April 7, 2017 and June 15, 2020 and distributed between […]
MedTech 100 roundup: Stocks brought back down again
A week after topping pre-pandemic highs, the medtech industry’s stocks were brought back down to earth in quick fashion. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 89.03 (Sep. 11), marking a -0.3% dip from the 89.29 points registered at the end of the […]
6 Georgia residents suing Sterigenics, BD over ethylene oxide exposure
The first six of what attorneys said could be more than 100 lawsuits were filed recently in Georgia against Sterigenics and Becton Dickinson (NYSE:BDX) by people who have lived, worked or attended school near those companies’ medical device sterilization plants. The plants use ethylene oxide (EtO) to sterilize millions of devices per year and reportedly have emitted thousands pounds of the […]
BD says 3 serious issues related to Alaris recall
Becton Dickinson (NYSE:BDX) today offered an update confirming three separate issues related to the recall of its BD Alaris infusion pumps. Three situations described in the recall, which was announced on June 30, were designated as FDA Class I recalls (the most serious kind), meaning that there is reasonable probability that use of the product will […]