FDAnews Device Daily Bulletin

Software failures accounted for a quarter of all device recalls in 2011, a new annual report from CDRH’s Office of Science and Engineering Laboratories (OSEL) reveals.

As devicemakers work with increasing numbers of suppliers, their risks of liability rise, making it imperative they have contracts and auditing policies in place to avoid costly lawsuits, recalls and adverse publicity, a product liability expert says.

The FDA user fee bill, which passed a final regulatory hurdle in the Senate Tuesday night, is a three-way win for patients, medical device makers and the FDA, industry lobby AdvaMed’s president & CEO Stephen Ubl said.

Vyzin, maker of the VESAG mobile personal emergency response system (MPERS), has received three key certifications for its product, including the important CE Mark necessary to access European markets.

Ultrasound vendor Ultrasonix Medical has received FDA clearance to market its SonixGPS technology for vascular access procedures.

A $5.1 million state tax break for Oberlin, Ohio-based Synapse Biomedical, which developed a way to ease breathing for Lou Gehrig’s disease patients, will allow it to add 60 jobs.

Dr. Allen’s device for prostate care enables a new therapy that treats prostate enlargement safely, contrary to different BPH medications.

The magnets in Apple’s third generation iPad may be a health risk to some users.