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FDA Clears Subtle Medical AI Technology for Images

[ Price : $8.95]

FDA clears a Subtle Medical 510(k) for the SubtlePET, an artificial intelligence-powered technology that the company says allows h...

FDA Clears Bausch & Lomb Astigmatism Contact Lens

[ Price : $8.95]

FDA clears a Bausch & Lomb 510(k) for its Ultra Multifocal for Astigmatism contact lens, a monthly silicone hydrogel lens.

Priority Review for Genentech Tecentriq sBLA

[ Price : $8.95]

FDA accepts for priority review a Genentech sBLA for a new indication for its Tecentriq.

Regulatory Review Period for Aspire Assist Device

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Aspire Bariatrics medical d...

Regulatory Review Period for Synergys Trulance

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Synergy Pharmaceuticals Tru...

Regulatory Review Period for Intercepts Ocaliva

[ Price : $8.95]

FDA determines for patent extension purposes the regulatory review period for Intercept Pharmaceuticals Ocaliva (obeticholic acid)...

QS Issues at MiBo Medical Group

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FDA warns MiBo Medical Group about Quality System violations in its manufacturing of the MiBo Thermoflo.

CGMP Violations in Barox Inspection

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FDA warns Koreas Barox about CGMP violations in its production of finished drugs.

FDA Recognizes Genetic Public Database

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FDA says its recognition of the ClinGen genetic data database will help speed development of novel diagnostic technologies to diag...

FDA Evaluating Mass Spectrometry in Drug Quality Control

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FDA says its researchers are evaluating a way to use mass spectrometry in drug quality control.