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RapidAI Wins Clearance for Lumina 3D

[ Price : $8.95]

FDA clears a RapidAI 510(k) for its Lumina 3D, an automated 3D imaging reconstruction device designed to replace manual workflows.

Adicet Wins Fast Track for Lupus Cell Therapy

[ Price : $8.95]

FDA grants Adicet Bio a fast-track designation for ADI-001 and its use in treating adult patients with refractory systemic lupus e...

FDA Alert on Breast Implant Illness

[ Price : $8.95]

FDA alerts healthcare professionals and patients about medical device reports detailing breast implant illness with systemic sympt...

AbbVie Antibiotic OKd for Abdominal Infections

[ Price : $8.95]

FDA approves an AbbVie NDA for Emblaveo (aztreonam and avibactam), a combination antibiotic for combination use with metronidazole...

Senate Dems Denounce FDA Communication Freeze

[ Price : $8.95]

A group of 24 Senate Democrats write HHS and urge an end to the ongoing and unprecedented freeze on all external communications an...

Alert on Bards Rotarex Atherectomy System

[ Price : $8.95]

FDA issues an alert about Bard Peripheral Vasculars Rotarex Atherectomy Systems due to risks of fracture or breakage.

Use Preemption in Failure-to-Market Cases: PRI

[ Price : $8.95]

A Pacific Research Institute white paper makes the case for a preemption defense in failure-to-market cases brought under state la...

Court Threatens Practice of Medicine Defense: Attorneys

[ Price : $8.95]

Cooley attorneys say a recent 4th Circuit Court of Appeals decision threatens the practice of medicine defense, giving FDA an addi...

Breakthrough Status for Mortality Prognosticator Tool

[ Price : $8.95]

FDA grants Onc.AI a breakthrough device designation for its Serial CT Response Score AI model, which the company describes as an a...

Medline Catheter Recall is Class 1

[ Price : $8.95]

FDA says the Medline Industries recall of integrated arterial catheters is Class 1.