FDAnews Device Daily Bulletin
Aug. 23, 2012 | Vol. 9 No. 166
Telemetry firm ScottCare has corrected all violations found during a site inspection earlier this year, earning an Aug. 13 close out letter from the FDA’s Cincinnati District Office.
Makers of Class IV devices that choose not to use a summary technical documentation-based license or amendment application must provide details on manufacturing and quality controls, a device-specific quality plan and process validation studies, according to a Health Canada final guidance.
House Republican and White House hopeful Ron Paul (R-Texas) aims to give doctors increased authority to prescribe terminal patients treatment with unapproved medical devices.
Medtronic’s business for neuromodulation devices recently received an FDA warning letter related mainly to the company’s processes for handling complaints, the devicemaker disclosed Tuesday.
Covidien is conducting another voluntary recall of medical devices.
A pioneering surgical blood salvage technology developed at the University of Strathclyde, Glasgow, Scotland, is set to transform the way major surgery is carried out by reducing blood loss in patients.
Aethlon Medical announced that the Defense Advanced Research Projects Agency (DARPA) has exercised an option agreement to proceed with year two of a five-year $6.8 million contract that was awarded to Aethlon on Sept. 30, 2011, under DARPA’s Dialysis-Like Therapeutics program.
Medtronic said sales of its heart defibrillators outpaced the global industry but remained weak, disappointing some investors who hoped the company would win more business after a product recall from rival St. Jude Medical.
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