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Getinge to limit US sales of heart devices after FDA safety warning
MedTech Dive via Yahoo Finance· 1 day agoDive Insight: Last week, the FDA advised providers against using Getinge’s Cardiosave intra-aortic...
FDA said it "never" inspected dental lab that made controversial AGGA device
CBS News· 4 days agoThe FDA never inspected Johns Dental Laboratories during more than a decade in which it made the...
FDA advises against using Cue Health COVID-19 tests, sends warning letter
MedTech Dive via Yahoo Finance· 3 days agoDive Brief: The Food and Drug Administration said Monday not to use Cue Health’s COVID-19 tests...
FDA Approves Expanded Use Of Bristol Myers Squibb's Breyanzi Cancer Cell Therapy For Previously...
Benzinga· 1 day agoWednesday, the FDA granted accelerated approval to Bristol Myers Squibb Co’s BMY Breyanzi...
FDA report highlights need to improve diversity in clinical trials
Clinical Trials Arena via Yahoo Finance· 1 day agoThe US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is...
FDA Pushes Review Date For Ascendis Pharma's Hormone Disorder Candidate By Three Months
Benzinga via Yahoo Finance· 2 days agoTuesday, Ascendis Pharma A/S (NASDAQ:ASND) announced that the FDA extended the review date for...
FDA APPROVES IMDELLTRA™ (TARLATAMAB-DLLE), THE FIRST AND ONLY T-CELL ENGAGER THERAPY FOR THE...
The Mammoth Times· 18 hours agoamgen_logo
11 Stomach-Turning Non-Food Items The FDA Allows In Our Food
Mashed via Yahoo News· 4 days agoThe FDA allows for some surprising non-food items to get into the food supply. Here are some of the...
FDA Issues Draft Guidance on Informed Consent for Sponsors, Investigators and Institutional Review...
JD Supra· 1 day agoThe U.S. Food and Drug Administration (FDA) recently issued a draft guidance document entitled, Key Information and Facilitating Understanding in Informed Consent. The draft ...
Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm
WKBN 27 Youngstown· 6 hours agoCAMBRIDGE, Mass., May 17, 2024 /PRNewswire/ -- Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced it has received 510(k) clearance from the U.S ...