Last week, the software received 510(k) clearance from the US Food and Drug Administration (FDA). This approval marks the first musculoskeletal solution under the agency’s QIH classification for software solutions that are based on artificial intelligence (AI).
Developed by a team of shoulder reconstruction surgeons, AI specialists and visual gaming programmers, among others, the PreView Shoulder software carries out automated segmentation and imaging data reconstruction.
This provides doctors with a visual model of surgical procedures before entering the operating room (OR) and does not require external processing of data.
Surgeons can adjust the size of an implant, as well as its location or orientation, by positioning it digitally into a three-dimensional view of the patient’s anatomy.
The software can help enhance surgical experiences by potentially lowering OR time and associated risks.
Shoulder Innovations chief commercial officer Dave Blue said: “PreView Shoulder is extremely valuable because it helps surgeons who use this next-generation pre-operative planning software tool achieve precision and accuracy in complex total shoulder replacement surgeries.”
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The company’s portfolio of shoulder replacement products includes multiple 510(k) clearances. Shoulder Innovations work to resolve surgical challenges and hope to help improve the lives of patients.
The addition of the PreView Shoulder software to its portfolio would allow the company to offer surgeons increased clarity for operations, Shoulder Innovations noted.
Shoulder Innovations CEO Rob Ball said: “Giving the best tools to surgeons results in better outcomes for patients.
“With our full platform of shoulder products and with the addition of the PreView Shoulder software, Shoulder Innovations is in a position to accelerate its impact on the shoulder replacement market.”
The company also offers a shoulder replacement implant system based on its InSet technology.