FDAnews Device Daily Bulletin

A Tennessee maker of wheelchair components received an FDA warning letter after the agency determined some products advertised on the company’s website had never been formally approved.

Makers of hip, knee and shoulder joint implants have two years from July 1, 2012, to apply for their products to be transitioned from Class IIb to Class III devices in Australia, according to the Therapeutic Goods Administration (TGA).

The FDA ordered St. Jude Medical to launch a three-year postmarket review on its recalled Riata and Riata ST defibrillator leads as well as for its QuickFlex LV CRT, QuickSite LV CRT, Riata ST Optim and Durata leads.

Spacelabs Healthcare has announced it has received FDA clearance for its Capnography Pod, according to a news release.

The FDA has cleared Siemens Healthcare’s syngo.PET Amyloid Plaque proprietary software and it is now available for use with PET and PET/CT systems.

The FTC on Thursday prohibited a mouthpiece manufacturer from making claims that its product reduces the risk of concussions.

More than half of U.S. hospitals, 54 percent, plan to purchase products designed to help integrate medical devices with EMRs over the next two years.

Michael Weickert wants to bring the reality of IV error out in the open and eliminate it.