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FDA issues 510(k) clearance for Implicity’s SignalHF1 algorithm
Medical Device Network via Yahoo Finance· 1 day agoLast year, Implicity launched a new algorithm for reducing alert fatigue in the remote monitoring of...
FDA said it never inspected dental lab that made controversial AGGA device
Medical Xpress· 5 days agoThe FDA never inspected Johns Dental Laboratories during more than a decade in which it made the...
Meditrina secures FDA clearance for Gen 2 hysteroscopy system
Medical Device Network via Yahoo Finance· 1 day agoMeditrina has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Gen 2...
FDA approves 2 Eylea biosimilars
Becker’s Hospital Review· 1 day agoThe FDA granted approval to Biocon Biologics' drug Yesafili and Samsung Bioepis and Biogen's drug Opuviz, the agency announced May 20. The two drugs are ...
Elon Musk’s Neuralink Gets FDA Green Light to Implant Brain Chips in More Humans
The New York Observer· 17 hours agoNeuralink, the brain-computer interface startup led by Elon Musk, has achieved another milestone as...
Exclusive | Elon Musk’s Neuralink Gets FDA Green Light for Second Patient, as First Describes His...
The Wall Street Journal· 1 day agoThe U.S. Food and Drug Administration gave a green light to Elon Musk’s Neuralink to implant its...
Hims & Hers Health says it will offer compounded GLP-1 drugs, despite FDA warnings
Morningstar· 13 hours agoHims & Hers Health Inc.'s stock (HIMS) jumped nearly 30% on Monday after the health and wellness platform said it would offer compounded GLP-1 drugs - products that the Food ...
Pedigree Dog Food Is Being Recalled Over "Loose Metal Pieces," FDA Says
Best Life· 20 hours agoRecalled Over Potential Toxicity, FDA Warns. On May 18, Mars Petcare issued a voluntary recall of...
Watkins-Conti scores FDA clearance for stress incontinence device
Medical Device Network via Yahoo Finance· 23 hours agoThe US Food and Drug Administration (FDA) has granted 510(k) clearance to US-based Watkins-Conti...
FDA Delays Decision on Ascendis' (ASND) Hormone Therapy Filing
Zacks via Yahoo Finance· 6 days agoPer the FDA, the data submitted by Ascendis (ASND) for its hormone replacement therapy constitutes a...