FDA Healthcare MedTech

Dexcom takes another step to keep CGMs in hospitals, while Abbott targets athletes

Released on September 18, 2020

Dexcom is launching a registry to track user outcomes in U.S. hospitals where its and rival Abbott’s continuous glucose monitors have […]

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Diagnostics FDA Healthcare

BD probes COVID-19 false positives with point-of-care systems

Released on September 15, 2020

Dive Brief: BD is investigating reports of false positive coronavirus test results in nursing homes from diagnostics run on its point-of-care […]

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FDA Healthcare MedTech

Abbott, Illumina, other medtechs shape guide conveying device risks to patients

Released on September 14, 2020

Dive Brief: The Medical Device Innovation Consortium (MDIC), a public-private partnership with a focus on regulatory science, has published an overview […]

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FDA MedTech Surgery

Olympus to distribute Alesi Surgical’s smoke control system

Released on September 10, 2020

Olympus announced today that it has entered into an exclusive agreement with UK-based Alesi Surgical to distribute that company’s 510(k)-cleared Ultravision […]

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Cardiology FDA Structural Heart

Medtronic tricuspid valve replacement device wins FDA breakthrough status

Released on September 9, 2020

Dive Brief: Medtronic on Wednesday simultaneously announced FDA breakthrough device designation and kickoff of an early feasibility study for a transcatheter tricuspid […]

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FDA MedTech

CMS agrees to cover ‘breakthrough’ medical devices

Released on August 31, 2020

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning. […]

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FDA MedTech Orthopedic

FDA clears SurGenTec synthetic bone graft

Released on August 27, 2020

SurGenTec announced today that it received FDA 510(k) clearance for its proprietary OsteoFlo NanoPutty quadphasic synthetic bone graft. Boca Raton, Fla.-based SurGenTec […]

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FDA MedTech Neuro

Valencia Technologies Files Pre-Market Approval (PMA) Application with U.S. FDA for eCoin® Peripheral Neurostimulator

Released on August 26, 2020

VALENCIA, Calif., Aug. 24, 2020 /PRNewswire/ — Valencia Technologies Corporation (“Valencia“), a private medical device company, today announced the filing of its pre-market approval […]

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Biotech FDA Healthcare

Hahn apologizes for convalescent plasma claim

Released on August 25, 2020

  Under intense criticism for his statement that convalescent plasma donated by former coronavirus patients could reduce COVID-19 deaths by 35%, […]

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Diagnostics FDA Healthcare

Ex-Trump FDA chief rails against new HHS policy on lab developed tests

Released on August 24, 2020

Dive Brief: Scott Gottlieb, the Trump administration’s former FDA commissioner, took to Twitter on Saturday strongly criticizing the decision of former colleagues […]

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Drug-delivery FDA MedTech

BD says 3 serious issues related to Alaris recall

Released on August 24, 2020

Becton Dickinson (NYSE:BDX) today offered an update confirming three separate issues related to the recall of its BD Alaris infusion pumps. Three […]

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Cardiology FDA MedTech

FDA grants IDE approval for Endospan’s aortic arch stent graft system

Released on August 19, 2020

Endospan has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to start the TRIOMPHE study […]

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