510(K) for intra-operative positioning device

September 6, 2019 0 By FM

Centerline Biomedical, Inc has received 510(k) clearance from the USFDA to market the Intra-Operative Positioning System (IOPS).

A non-radiation-based surgical navigation system for minimally invasive surgery, IOPS leverages anatomical mapping algorithms and electromagnetic tracking technology to provide three-dimensional colour visualization and guidance in real-time during endovascular procedures.

The system, developed at Cleveland Clinic’s Heart and Vascular Institute, addresses the need for a path away from X-ray fluoroscopy which is currently the standard of care, despite severe visualization challenges.

Once in the market, Centerline hopes to show significant value to the technology by reducing procedure cost while improving radiation safety and patient outcomes.

“We hope to use this game-changing technology to revolutionise our approach to vascular procedures and imaging,” said Dr Matthew Eagleton, chief of vascular surgery at Massachusetts General Hospital and Chair of the company’s Scientific Advisory Board, in a statement.