Where recalled devices have already been implanted ... FDA records. The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls ...

The FDA has cleared a device aimed at improving access to the heart’s outer surface for diagnostic and therapeutic interventions without the use of an exposed needle. The device, called ViaOne ...

Abbott's first-of-a-kind smartphone compatible heart monitor has been approved by for use in the US. Now with the FDA's blessing ... of its kind available and is implanted just under the skin ...

Medtronic has issued a recall for several aortic root cannula devices ... FDA’s most serious, affects the DLP Aortic Root Cannula, MiAR Cannula and DLP Aortic Root Cannula with Vent Line used in ...

Tens of millions of Americans live with medical devices ... analysis of the FDA's database of adverse events. Implanted in more than a half-million Americans with serious heart disorders, the ...

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 ...

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units ...

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 ...

The US Food & Drug Administration (FDA) has approved EBR Systems' (ASX:EBR) WISE wireless pacemaker device, thus opening a ...