FDA Device Approvals
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FDA finalizes new breakthrough device designation rule
The larger regulatory modernization efforts, which include updates to the 510(k) regulatory approval pathway and the DeNovo Clearance review process are part of the FDA’s Medical Device Safety Action Plan.
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FDA considering imposing 10-year limit when manufacturers choose older predicates
FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers develop a new product showing substantial equivalence.
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Trayt Health Seeks to Increase Access to Diagnoses and Treatments
CEO Malekeh Amini explains how Trayt Health can bridge the gap for patients seeking neurological care.
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Improving Communication Between Patients and Providers
Sarah Shillington, Chief Customer Officer notes how Artera’s omnichannel platform works.
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Devices & Diagnostics, Health IT, Hospitals
Verizon gets FDA clearance to expand remote monitoring platform to iOS users
Verizon has received FDA clearance that will expand a physician-facing patient engagement tool to capture […]
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Devices & Diagnostics, Hospitals
EarlySense gets FDA device approval for patient monitor update with benchmarking tool
Medical device maker EarlySense has received a green light for an updated version of its […]
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Texas medical device company scores FDA nod for hammertoe fixation system
San Antonio, Texas-based BioMedical Enterprises received FDA clearance for its HammerLock Nitinol Intramedullary Fixation System upgrade. The […]
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Devices & Diagnostics, Startups
FDA to 23andMe: Stop selling spit kits
Star startup 23andMe got slammed with an FDA warning letter Nov. 22. The letter says […]
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BSX scores FDA device approval for drug-eluting stent for coronary artery disease patients
Boston Scientific (BSX) received FDA device approval for its Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent […]
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Illumina gets FDA greenlight for first set of next generation sequencing devices
Illumina (NASDAQ: ILMN) got marketing authorization from the U.S. Food and Drug Administration for its […]