FDAnews Device Daily Bulletin

A warning letter may be in St. Jude Medical’s future, company CEO Dan Starks announced during a Wednesday third quarter earnings call.

Health Canada plans to shift health product monitoring to a total product lifecycle approach in the coming years, the agency said in a Sept. 12 document detailing a new framework for health product vigilance.

Complying with regulation so that device makers avoid being slapped on the wrist by the FDA is a narrow effort compared with building high-quality devices that meet the needs of patients.

Merit Medical Systems announced that the FDA has completed its evaluation of Merit’s corrective actions in response to a warning letter issued to the company dated Jan. 30, 2012, related to the Merit Laureate Hydrophilic Guidewire.

For the female executive from the Hungarian firm which is authorized to approve medical devices throughout Europe, the brochure outlining a proposal for a new “metal-on-metal” hip implant should have rung alarm bells.

Merit Medical Systems announced that the FDA has completed its evaluation of Merit’s corrective actions in response to a warning letter issued to the company dated Jan. 30, 2012, related to the Merit Laureate Hydrophilic Guidewire.

For two decades, doctors have used a dime-sized plug made by St. Jude Medical to close holes found in the hearts of stroke victims in a surgery that’s based largely on a medical theory.

ZOLL Medical, a manufacturer of medical devices and related software solutions and a wholly owned U.S. subsidiary of Asahi Kasei, has established Asahi Kasei ZOLL Medical Corporation as its Japanese subsidiary effective Nov. 5.