News from the FDA, medical OEMs

Advancing digital health technology

The U.S. Food and Drug Administration (FDA) is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH), furthering the advancement of digital health technology, including mobile health devices, software as a medical device (SaMD), wearables when used as a medical device, and technologies used to study medical products.

“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” says FDA Commissioner Stephen M. Hahn, M.D. “[It] will provide centralized expertise and serve as a resource for digital health technologies and policy.”

The agency is appointing Bakul Patel as the first director. He has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010. 

Added clearance for SI revision

Life Spine received clearance from the U.S. Food & Drug Administration (FDA) to market a SI revision offering and additional claims for the SImpact Sacroiliac Joint Fixation System. The new clearance adds a 14.5mm diameter screw to its SI fixation portfolio. The new size focuses on filling a missing gap in the market for revision surgeries. The larger screw joins the current offering of self-drilling 12mm and 8mm diameter threaded implants.

Additional claims, indications, and length offerings have also been granted to the SImpact system. The implant is self-harvesting and can be used prophylactically in long construct cases. All implants in the system are now offered in overall lengths of 30mm to 110mm in 5mm increments. The 8mm diameter lag screws now include the aggressive self-drilling screw tip geometry that allows for minimized surgical steps. http://www.lifespine.com