Browsing: FDA

In the first half of 2026, the Food and Drug Administration has authorized more medical devices than in the same…

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Dive Brief: The Food and Drug Administration has dropped a warning letter against wearable device firm Whoop following changes the…

Dive Brief: Johnson & Johnson’s Abiomed alerted physicians to a risk associated with eight instances of major bleeding in patients treated…

Zoll received a warning letter from the Food and Drug Administration citing quality concerns and problems with how the firm…

Dive Brief: An ongoing shortage of breast biopsy needles is expected to continue through March 2027, the Food and Drug…

FDA audits are inevitable for medical device manufacturers. For early-stage and growth-stage companies, these regulatory assessments often occur at pivotal…

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