Relating to certain of Medtronic’s Newport ventilator range, users have been advised to remove the affected units from ...

The U.S. Food and Drug Administration (FDA) announced voluntary recalls this week on products made and distributed by Supreme Service Solutions, The Coastal Companies, and Isabelle's Kitchen Inc ...

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 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 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 ...

BiVacor announced today that it received FDA breakthrough device designation for ... ve spent decades proving that a fully implantable, total artificial heart isn’t just possible, it’s ...

BiVACOR, a clinical-stage medical device company ... Artificial Heart (TAH), today announced that its device has received Breakthrough Device Designation from the U.S. Food and Drug Administration ...

“Until now, advanced heart devices implanted in Israel were essentially left-ventricle assist devices, which supported only part of the natural heart. These are not suitable for patients with total ...

The U.S. Food and Drug Administration has approved the first at-home self-collection device for cervical cancer screening in the United States, called the Teal Wand, according to the women’s health ...

Boston Scientific will eliminate jobs after discontinuing global sales of its Acurate aortic valve replacement systems that treat the heart failure-causing condition aortic stenosis, the medtech ...