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Vyaire Recalls AirLife Resuscitators

[ Price : $8.95]

Vyaire Medical recalls certain AirLife Manual Resuscitators due to a manufacturing defect.

Hearing Challenges FDA Rule on LDTs

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A House Energy and Commerce Health Subcommittee hearing discusses the need to legislatively reform FDAs oversight of laboratory-de...

Phase 3 Keytruda Miss in Lung Cancer

[ Price : $8.95]

Merck says its Phase 3 KEYLYNK-006 trial evaluating Keytruda (pembrolizumab) in combination with maintenance Lynparza (olaparib) d...

Abiomed Recalls Impella Blood Pumps

[ Price : $8.95]

Abiomed recalls its Impella Left Sided Blood Pumps because the pump catheter may slice the hearts left ventricle wall during proce...

Elixir Gets Breakthrough for DynamX BTK

[ Price : $8.95]

FDA grants Elixir Medical a breakthrough device designation for its DynamX BTK System, an adaptive implant for use in treating nar...

Check Key Info in Informed Consent

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Two SheppardMullin attorneys analyze a recent FDA draft guidance on informed consent and suggest steps that clinical trial sponsor...

Non-Interventional Studies Guidance

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FDA publishes a draft guidance on using non-interventional studies for drug and biological products to develop real-world evidence...

CBER AI/ML Web Page

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CBER launches a new Web page on its approach to using AI/ML in regulatory oversight of products it regulates.

Fujifilm AI Colonoscopy Polyp Detector Cleared

[ Price : $8.95]

FDA clears a Fujifilm Healthcare Americas 510(k) for CAD EYE, an artificial intelligence detection system for endoscopic imaging.