FDAnews Device Daily Bulletin

Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials.

California’s 2,000 biomedical companies face an extra layer of regulation: The state requires drug and device manufacturers to undergo an inspection by the California Food and Drug Branch in addition to federally mandated FDA inspections.

The FDA issued a recall for B. Braun’s Infusomat Space Pump following reports of a faulty free flow clip catch.

The past couple of years have seen a steady drumbeat of concerns by some lawmakers that health regulators are doing too little to protect consumers from hastily approved devices that can cause injury or even death.  

Medtronic investors accused the medical device maker’s directors of making misleading statements about their marketing of the company’s bone growth-stimulating device for off-label uses, causing the company to repurchase more than $2.8 billion of its own stock at inflated prices.

SuperDimension is in the process of being acquired by a U.S. firm for $350 million, Calcalist reported, without saying where it got the information.

In a meeting on March 8, the Medicare Payment Advisory Commission recommended that the U.S. Congress direct the Secretary of Health and Human Services to develop a new fee-for-service benefit design that could include higher patient co-payments for advanced diagnostic imaging services.

For pacemakers and other implantable medical devices there are three key factors: extreme reliability, small size and long longevity.

Irvine-based medical devicemaker Masimo is working toward what its chief executive calls a “brighter 2012” in the wake of recent challenges.