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Subtle Medical Imaging Software Cleared

[ Price : $8.95]

FDA clears a Subtle Medical 510(k) for its SubtleSYNTH, which uses deep learning to generate synthetic Short Tau Inversion Recover...

Baxter Recalls Volara System Ventilator Adapter

[ Price : $8.95]

Baxter International recalls (Class 1) certain lots of the Volara system single-patient use circuit and blue ventilator adapter as...

Comments Extended for Guide on Platform Technology

[ Price : $8.95]

Federal Register notice: FDA extends the comment period on its draft guidance entitled Platform Technology Designation Program for...

FDA Opening Rare Disease Innovation Hub

[ Price : $8.95]

CDER director Patrizia Cavazzoni and CBER director Peter Marks say they are co-leading a new FDA Rare Disease Innovation Hub.

Blood Donor Eligibility Compliance Policy

[ Price : $8.95]

FDA publishes a guidance with its compliance policy about blood establishments failing to comply with some donor eligibility requi...

Endo Recalls 1 Lot of Clonazepam

[ Price : $8.95]

Endo recalls (Class 1) one lot of clonazepam orally disintegrating tablets 0.25 mg due to mislabeling on the cartons of some packs...

Hyperfine AI Swoop MR Software Cleared

[ Price : $8.95]

FDA clears a Hyperfine 510(k) for the ninth generation of artificial intelligence-powered Swoop magnetic resonance software.

Bayer Looking to Expand Nubeqa Indication

[ Price : $8.95]

Bayer says it will present positive results from a Phase 3 Nubeqa prostate cancer trial to FDA to consider a potential indication ...

Priority Review for Atara Gene Therapy

[ Price : $8.95]

FDA accepts for priority review an Atara Biotherapeutics BLA for gene therapy tabelecleucel, indicated as monotherapy for treating...

Almost 3,000 Establishment Inspections in FY 2023

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The FDA FY 2023 drug and medical device establishment inspection report lists registered establishments and inspections by type an...