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 Food and Drug Administration (FDA) has cleared the Jewel ® Patch Wearable Cardioverter Defibrillator (Patch-WCD) for adult patients aged 18 years and older who are at risk for sudden cardiac ...

Consumers Union recommends that the FDA: Require that implants and other "life-sustaining" devices be tested ... connect them to the heart. There have been two major recalls, in 2007 and ...

The US Food and Drug Administration (FDA) has approved the expansion of BiVACOR’s early feasibility study evaluating its titanium total artificial heart (TAH) to additional participants.

Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, ...

Abbott Laboratories has announced that its implantable heart device, MitraClip, has not been recommended for approval by reviewers at the US Food and Drug Administration. Clinical trials ...

The FDA elevated a recall of intraocular lenses currently ... announced it would begin pulling certain models of its enVista implants in late March and early April, including its Aspire and ...

Carmat is preparing to commence implants ... tumour. "FDA conditionally approves second cohort of Carmat’s artificial heart study" was originally created and published by Medical Device Network ...

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 ...

Patients awaiting a heart transplant are often implanted with an ... and funding for pediatric heart devices. The network is working with the U.S. Food and Drug Administration (FDA) to expand ...

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 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 ...