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With medical devices, recalls are not always what they seem. In some recalls, including some of the most serious, the FDA and the manufacturers let doctors and hospitals continue to use the devices.
The FDA has approved expanded labelling for Abbott's CardioMEMS HF System, an implantable sensor that provides an early warning of worsening heart failure, that could make it an option for more ...
The SOLVE-CRT trial has delivered promising results for heart ... devices—pacemakers, ICDs, or CRTs—using a subcutaneous ultrasound Transmitter to power an ultra-compact Electrode implanted ...
What to know. ‘Yellowstone’ baked beans inspired by TV show recalled by FDA for undeclared allergen Volvo recalls more than 400,000 cars for rearview camera issue: See impacted models Tomatoes ...
Patients awaiting a heart transplant are often implanted with ... for pediatric heart devices. The network is working with the U.S. Food and Drug Administration (FDA) to expand the use and monitor ...
The FDA has approved a new use for AstraZeneca’s Farxiga (dapagliflozin) to reduce risk of cardiovascular death and hospitalisation with heart failure, in adults with reduced ejection ...
French company Carmat has secured conditional approval from the US Food and Drug Administration (FDA ... to the implanted prosthesis. In 2023, the company announced the first Aeson heart ...
FDA extended aficamten's PDUFA date to Dec. 26, citing REMS review. No new clinical trials or data have been requested by the FDA. Don’t miss this list of 10 overlooked stocks—including one pa ...