FDAnews Device Daily Bulletin

Healthcare regulatory affairs professionals in North America saw their salaries and bonus levels rise by an average of three percent in 2011, making modest but notable compensatory gains during a year punctuated by severe cutbacks and grinding economic malaise, a new report finds.

Sunrise Medical’s GMP slips related to one of its wheelchairs led to two of five observations on a Form 483 issued for a Jan. 11-19 inspection.

Stryker isn’t downtrodden in light of the FDA’s decision to restrict use of the Wingspan brain stent system to a narrower group of patients.

Miraculins will receive $130,000 in grant funding from the Manitoba Commercialization Support for Business Program to support commercialization of its PreVu Non-Invasive Skin Cholesterol Test.

The recalled Riata and Riata ST cardiac leads have higher electrical failure rates over the long term compared with other available leads, researchers confirmed.

Parker Waichman has filed a lawsuit on behalf of a New York woman who suffered permanent and substantial injuries, allegedly due to the Gynecare Prolift Total Pelvic Floor Repair System and Miniarc Precise Sling transvaginal mesh implants.

Insulin pumps are designed to be convenient and easy to use, but those features may make them more vulnerable to a hacker, a new report says.

GeNO announced it has received the green light from the FDA to market its inhaled nitric oxide delivery system, GeNOsyl MV-1000.