FDAnews Device Daily Bulletin

Edwards Lifesciences garnered FDA approval of an expanded indication for the Sapien heart valve Oct. 19, just ahead of the company’s announcement of 9 percent sales growth in the 2012 third quarter.

A U.S. district court judge concluded the FDA “acted arbitrarily and capriciously” in designating a drug-device combination product as one in which the drug is the primary mode of action, scoring a win for French devicemaker Prevor.

A former sales manager at device manufacturer Orthofix pled guilty in Pennsylvania federal court to healthcare fraud in connection with the forging of patient records to obtain $250,000 in illegitimate Medicare reimbursements, prosecutors said.

As noted before, October has not been kind to St. Jude Medical. And now the Minnesota device maker has been hit with five back-to-back downgrades from equity analysts.

Fidelity Growth Partners has invested $75 million in Indian medical equipment supplier Trivitron Healthcare.

Since 1992, the U.S. has consistently spent about six percent of its national healthcare dollar on medical devices, according to a new report.

A Texas Medicare administrator is wrongly denying coverage for a procedure to relieve pain from spinal stenosis, a medical device-maker claims in court.

Michael Mahoney is officially taking charge at Boston Scientific, becoming its CEO after a one-year stint as president at the device maker.