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Becton, Dickinson and Company

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Latest From Becton, Dickinson and Company

For Second Time This Month, Medtronic Announces Class I FDA Recall Related To HeartWare System Component

Medtronic, Baxter and BD are all facing recalls, with Medtronic finding yet another issue with HeartWare HVAD systems. Separately, the FDA put a Baxter respiratory device recall into Class I, and BD announced a recall on intraosseous devices.

FDA Enforcement

Three OTC COVID-19 Tests Win FDA Clearance After Template Updates

Access Bio’s CareStart COVID-19 Antigen test gives results within 10 minutes, Becton, Dickinson’s BD Veritor within 15 minutes and InBios International’s SCoV-2 Ag Detect within 20 minutes. All three hold emergency use authorizations.

Diagnostics Coronavirus COVID-19

Becton, Dickinson Has First EUA In US For Smartphone-Linked Rapid Antigen Test

BD has EUA for Veritor At-Home COVID-19 rapid antigen test using smartphone vision technology to interpret and digitally display results. Researchers at biotech firms and medical schools measure advantages of at-home use of rapid antigen tests over quantitative real-time polymerase chain reaction tests.

Coronavirus COVID-19 OTC Devices

FDA Grants EUA For BD Blood Collection Tubes To Soften Shortage

Increased demand tied to COVID-19, plus supply chain difficulties, led to the blood collection device shortage, the US agency says.

Regulation FDA
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