Ortoma AB (publ), a trailblazer in the realm of orthopedic technology, announces that it has obtained FDA 510(k) clearance for OTS™ Hip. This approval allows Ortoma to market OTS™ Hip in the United States, the largest market worldwide for orthopedic surgical equipment. The OTS™ platform is a surgical system powered by AI, enhancing precision, efficiency, and surgical outcomes.

Linus Byström, commented, "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 US."

The OTS™ Hip system in its latest version incorporates cutting edge technology with advanced machine learning algorithms. This version has now received FDA 510(k) clearance, which serves as a cornerstone for the launch of OTS™ Hip in the U.S. market.

About OTS™
Ortoma Treatment Solution (OTS™) is a product used for orthopedic procedures, specifically for hip surgery, that includes OTS™ Hip Plan and OTS™ Hip Guide for preoperative planning, intraoperative navigation, and postoperative follow-up of hip implant surgery. The system's software, which is based on artificial intelligence, enables improved accuracy, efficiency, and surgical results.

Ortoma - Improved Performance
For additional information, please contact:
Ortoma CEO Linus Byström
e-post: [email protected]

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Ortoma AB published this content on 13 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 March 2024 08:47:06 UTC.