FDAnews Device Daily Bulletin

As widely anticipated in the wake of the PIP breast implant and metal-on-metal hip scandals, the European Commission is proposing that certain high-risk medical devices undergo more rigorous premarket scrutiny akin to that required by the FDA.

A Tennessee maker of wheelchair components received an FDA warning letter after the agency found problems with the company’s documentation and complaint-handling procedures.

Covidien, a leading global provider of healthcare products, will showcase some of its most innovative surgical products at the American College of Surgeons (ACS) annual clinical congress held here at McCormick Place through Oct. 4.

Florida-based stent maker Bolton Medical won FDA clearance for its thoracic-specific stent-graft system, the company announced today.

Sunshine Heart, a global medical device company focused on innovative technologies for moderate to severe heart failure, announced it has received conditional approval from the FDA for an investigational device exemption (IDE) for its flagship C-Pulse Heart Assist System.

An FDA panel voted unanimously on Friday to recommend approval of the first retinal prosthesis device intended to help nearly blind patients regain a small part of their vision.

VBOX today announced that the U.S. Food and Drug Administration has approved its Trooper portable oxygen concentrator for prescription oxygen therapy.

A Winnipeg woman is suing the manufacturers of a medical device for $5 million, alleging the device implanted in her 10 years ago is defective and deteriorating inside her body but can’t be removed.