FDAnews Device Daily Bulletin

Manufacturers hoping the FDA might adopt a more European-style approach to device approval got a strongly negative signal in a May agency report.

User fees for medical device license and renewal rose 2 percent in Canada, effective April 1.

Medema Production A/S has issued a recall for its Mini Crosser M1 scooters.

The Federal Communications Commission announced a plan to allocate spectrum bandwidth for wireless medical sensors that could be used to monitor patients’ health.

A medical imaging OEM trade lobby said an excise tax scheduled to go into effect next year would not be a “windfall” for their businesses, in response to the wording of a letter from hospitals and group purchasing organizations urging the IRS to ensure devicemakers shoulder their share of the cost of health reform.

Devicemaker Boston Scientific said it received U.S. approval for a new type of stent to treat blocked arteries in the legs.

A non-invasive eye imaging system developed by medical device company Bioptigen now has regulatory clearance for use on patients in the United States.

China’s Department of Health drew public attention to a medical device alert on the Clever Chek blood glucose monitoring system, which is a home-use blood glucose monitoring system for visually impaired patients.

ApniCure announced that the FDA has granted the company 510(k) clearance to market its Winx Sleep Therapy System in the United States.