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GE Recalls Ventilator Air Compressors

[ Price : $8.95]

GE Healthcares Datex-Ohmeda unit recalls its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) after the comp...

Maquet Cardiovascular Recalls Chest Drain

[ Price : $8.95]

Maquet Cardiovascular recalls its Atrium Express Dry Suction Dry Seal Chest Drain in response to a related components recall by an...

Congressional Dems Ask SCOTUS Mifepristone Reversal

[ Price : $8.95]

More than 260 congressional Democrats ask the Supreme Court to reverse lower court rulings restricting the use of the medical abor...

Respironics Reports 111 Deaths in 3Q 2023: FDA

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Just two days after agreeing to a consent decree, FDA says that Philips Respironics reported over 7,000 medical device reports and...

Guide on Monoclonal Antibodies Docket Correction

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Federal Register notice: FDA corrects a 12/21/2023 notice announcing the availability of a final guidance entitled Development of ...

FDA to Down-classify Many IVDs

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CDRH director Jeffrey Shuren says the Center will propose down-classifying many in vitro diagnostic tests from Class 3 to Class 2 ...

World Cancer Day Treatment Virtual Discussion

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FDA and EMA schedule a 2/1 virtual public discussion on innovative therapies for some cancers to mark World Cancer Day.

Defender Pharma Complete Response on Nausea Drug

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FDA sends Defender Pharmaceuticals a complete response letter on its NDA for intranasal scopolamine (DPI-386) for preventing nause...

Musk Reports Implanting 1st Chip in Human Brain

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Neuralink founder Elon Musk announces the first chip implant in the brain of a human clinical trial participant.

Panel to Discuss Geron Imetelstat NDA

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Federal Register notice: FDA announces a 3/14 Oncologic Drugs Advisory Committee meeting to discuss a Geron NDA for imetelstat for...