It’s a validation of a concept we’ve spent decades proving that a fully implantable ... heart failure where current treatments, including LVADs, are not viable. The FDA’s Breakthrough Device ...

The US Food and Drug Administration (FDA) has granted breakthrough device designation to BiVACOR’s titanium Total Artificial ...

The FDA’s Breakthrough Device program is reserved for ... concept we’ve spent decades proving that a fully implantable, total artificial heart isn’t just possible, it’s necessary," said ...

In 2013, the FDA approved an implantable device to treat leaky heart valves ... in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit ...

In 1982, the U.S. Food and Drug Administration ... 7 as a permanent artificial heart, Jarvik said, the device was used hundreds of times as a temporary implant for patients until they could ...

Jarvik is best known for designing the Jarvik-7, an artificial heart made of plastic and aluminum. It was implanted in Barney ... Eventually, the U.S. Food and Drug Administration (FDA) stopped ...

[Image courtesy of EBR Systems] EBR Systems today announced the first commercial patients in the U.S. successfully implanted with its FDA-approved ... s only such device for heart failure.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced financial results for its fourth quarter (Q4) and fiscal year 2025 (FY25), which ended April 25, 2025.

Coating for the guidewires could come off and get left in patients, which could result in extended or additional procedures.

The company announced in April that its device received FDA clearance to be implanted to record, monitor and stimulate electrical activity on the brain’s surface for up to 30 days. The device ...

The FDA has issued a Class I recall for multiple anesthesia breathing circuit kits due to cracks in the hose that could cause inadequate ventilation.  The affected products include VentStar 220 as ...