(NEXSTAR) – The Food and Drug Administration (FDA) announced Monday that two heart pump products are being recalled after reports of 14 deaths and hundreds of injuries were associated with the ...
Initiated by Abbott/Thoratec and deemed Class I by the FDA, the recall is in response to reports of 70 injuries and two ...
In the latest notice, which follows a February recall of the device for a separate issue, Abbott took action due to reports of blood leakage and air entrapment.
A team at the Mayo Clinic and Eko Health trained the AI program by having it listen to more than 100,000 patients' recordings. Cole Brings Plenty: Yellowstone 1923 actor found dead days after ...
The US Food and Drug Administration (FDA) has issued its highest-level alert about a heart pump that has been linked to 49 deaths and 129 injuries. The Impella left sided pumps are used to ...
At least 224 people with diabetes have reported injuries linked to a defective iOS app that caused their insulin pumps to shut down prematurely, according to the US Food and Drug Administration (FDA).
(Reuters) -The U.S. drug regulator on Friday added a warning to the literature that accompanies Pfizer Inc/BioNTech and Moderna COVID vaccine shots to indicate the rare risk of heart inflammation ...
STOCKHOLM--Getinge shares are under pressure Wednesday after the company said it will limit sales of some of its heart devices in the U.S. as regulators recommended healthcare providers to ...
Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs). The five stages of the ...
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A drug used primarily to treat depression was recalled on April 18, after it was found to contain nitrosamine impurities above acceptable levels, the Food and Drug Administration (FDA) said yesterday.