Naviswiss receives FDA 510(k) clearance for hip replacement preoperative planning app
The FDA granted 510(k) clearance to Swiss-based medical technology company Naviswiss for its CT-based preoperative planning application for hip replacement, according to a press release.
The application, Naviplan, uses CT technology to help surgeons in positioning joint implants, automatic 3D segmentation and advanced image processing. Naviplan data is then processed in the Naviswiss navigation platform, which is used intraoperatively. The CT-based navigation system and Naviplan will be released to orthopedic care centers in the U.S. during the fourth quarter of 2021.
"Naviplan and CT-based navigation are an important addition to the Naviswiss portfolio and completes our offering for navigated hip replacement," Jan Stifter, Naviswiss CEO and board member, said in the release. "We now have two patient-specific options where the surgeon determines the best application for the procedure. CT-based navigation may be needed in difficult deformity cases while kinematic registration may be preferred in more traditional surgeries. The surgeon can rely on highly accurate guidance in placing the acetabular components."