Sean Fenske, Editor-in-Chief03.14.24
The U.S. Food and Drug Administration (FDA) has granted a 510(k) clearance to Ortoma AB for its OTS Hip system. This technology platform is powered by artificial intelligence, which the company claims enhances precision, efficiency, and surgical outcomes.
Company CEO Linus Byström, said, “This marks a critical milestone for Ortoma in commercializing OTS Hip in the vast U.S. market. The regulatory clearances we pursue are pivotal for our market position and we are looking forward to bring our solution to the U.S.”
The Ortoma Treatment Solution (OTS) includes the Hip Plan and Hip Guide to enable preoperative planning, intraoperative navigation, and postoperative follow-up after a hip procedure.
Company CEO Linus Byström, said, “This marks a critical milestone for Ortoma in commercializing OTS Hip in the vast U.S. market. The regulatory clearances we pursue are pivotal for our market position and we are looking forward to bring our solution to the U.S.”
The Ortoma Treatment Solution (OTS) includes the Hip Plan and Hip Guide to enable preoperative planning, intraoperative navigation, and postoperative follow-up after a hip procedure.