FDAnews Device Daily Bulletin

The unsealing of a hence unknown 2009 qui tam (whistleblower) lawsuit filed against the FDA by seven former CDRH scientists embroiled in an ongoing email monitoring scandal may provide evidence the employees were sharing proprietary information, one legal expert says.

The FDA has classified Fresenius Medical Care’s recent warning of the company’s GranuFlo and NaturaLyte dialysis products a Class I recall.

St. Jude Medical’s coming overhaul and massive layoffs were attributable partly to the 2.3 percent medical device tax taking effect Jan. 1.

In what experts say is a novel legal tactic to resolve hundreds of ongoing investigations simultaneously, the Justice Department is emailing hospitals across the country with instructions to examine questionable implantable defibrillator surgeries on Medicare patients and estimate potential penalties under the False Claims Act.

Science guru and breakfast radio presenter Adam Spencer has described it as “The New Inventors meets The Apprentice meets ER.”

The Saudi Food and Drugs Authority (SFDA) has revealed that it destroyed this year medical equipment worth $23.5 million stored in humid and hot places that made them ineffective.

Stanford researchers have developed a cardiac device that fits on a pin head and derives power from radio waves from outside the body.

A Belgrade-based company that makes medical devices has received $25 million from a New York investment firm.