Browsing: letter

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

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

Medline is removing certain angiographic syringes from the market due to problems with the devices becoming loose or disconnected. Medline…

Dive Brief: Dive Insight: The FDA sent the warning letter after an inspection of Exactech’s Sarasota, Florida, facility in July.…

Dive Brief: Abbott received a warning letter from the Food and Drug Administration related to its FreeStyle Libre continuous glucose…

Dive Brief: Beta Bionics has received a warning letter from the Food and Drug Administration following an inspection last year,…

Sometimes, the line between medical and wellness products can blur. Regulators’ pushback on a blood pressure feature that Whoop incorporated…

The Food and Drug Administration sent a warning letter to Philips related to quality issues at three facilities that manufacture…

Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback. A warning…

Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback. Dive Brief:…