March 14, 2012

Vol. 9 No. 52

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Synthes Slapped With Wrongful Deaths Suit, FDA Warning Letter

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. Read More

Bill Would End Double Inspections of California Plants

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. Read More

Potential Breakage of Clip Leads to Pump Recall

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

Consumer Reports Taps Ire Over Bad Medical Devices

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.   Read More

Medtronic Investors Sue Over $3 Billion Inflated Stock Buyback

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. Read More

SuperDimension to Be Acquired for $350 Million, Calcalist Says

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. Read More

MedPAC Proposes Medicare Benefit Reform

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. Read More

New Design Techniques Enable Extremely Reliable Medical Devices

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

Masimo Sees Sunny Year Ahead After Partly Cloudy 2011

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