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Advisors Asked for ProSense Benefits, Risks

[ Price : $8.95]

FDA raises questions to be considered by members of its General and Plastic Surgery Advisory Committee about IceCare Medicals ProS...

FDA OKs LumiThera Dry AMD Treatment

[ Price : $8.95]

FDA grants de novo authorization to LumiTheras Valeda light delivery treatment for dry age-related macular degeneration.

Caris Companion Diagnostic for Cancer Approved

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FDA approves Caris Life Sciences MI Cancer Seek and its use as a companion diagnostic to identify cancer patients for treatment wi...

ACLA Views on PCCP Draft Guidance

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The American Clinical Laboratory Association submits comments to an FDA draft guidance on medical device predetermined change cont...

RFK Jr. Says Some FDA Departments Have to Go

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In an interview the day after the election, president-elect Donald Trumps top health advisor Robert F. Kennedy Jr. says there are ...

Breakthrough Designation for SeaStar Dialysis Device

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FDA grants a fourth breakthrough device designation for SeaStar Medicals Selective Cytopheretic Device.

Objectionable Conditions at Hospital IRB

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FDA warns the Kittanning, PA-based Armstrong County Memorial Hospital IRB about objectionable conditions identified in a Bioresear...

FDA Cant Regulate AI on its Own: Califf

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FDA commissioner Robert Califf says collaboration with external stakeholders is needed to adequately monitor and regulate artifici...

Acadia Unloads Priority Voucher for $150 Million

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Acadia Pharmaceuticals sells its Rare Pediatric Disease Priority Review Voucher for $150 million.

FDA OKs Envoy Medical Cochlear Implant Study

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FDA approves an Envoy Medical IDE for its pivotal study of the Acclaim Fully Implanted Cochlear Implant.