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Guide on Clinical e-Thermometer

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.

Empatica Adds 2 Biomarkers to Monitoring Device

[ Price : $8.95]

FDA clears an Empatica 510(k) for two new digital biomarkers for its Empatica Health Monitoring Platform pulse and respiratory ra...

Harvard Drug Group Recalls Eye Drops

[ Price : $8.95]

The Harvard Drug Group recalls all lots of polyvinyl alcohol, 1.4% lubricating eye drops and lubricating tears eye drops (dextran/...

FDA/Moderna Revolving Door Analyzed

[ Price : $8.95]

A BMJ investigation looks at the case of two former FDA vaccine officials who now work for Moderna.

Lilly Sees Alzheimers Drug Decision Delay

[ Price : $8.95]

Eli Lilly says that an FDA review decision for its experimental Alzheimers drug donanemab has been pushed back to the first quarte...

Clinical e-Thermometer Enforcement Policy

[ Price : $8.95]

FDA posts a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.

Enforcement Guide on PMA/HDE Modifications

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Certain Supplements for Approved Pre...

Fix Pulse Oximeter Biases, 25 State AGs Tell FDA

[ Price : $8.95]

The attorneys general from 25 states list six things FDA should do immediately to address the concern that pulse oximeters are not...

FDA Seeking Diabetes DHT Info

[ Price : $8.95]

CDRH asks for public comments on several questions to help it advance the development of digital health technologies for use in di...

FDA OKs Abbott HPV Diagnostic Test

[ Price : $8.95]

FDA approves Abbotts Alinity m molecular human papillomavirus (HPV) diagnostic test.