Genesis Software Innovations received 510(k) clearance from the FDA for its PreView Shoulder software for joint replacements.
The software allows orthopedic surgeons to develop preoperative plans based on CT imaging, according to a May 5 news release. Surgeons will be able to optimize implant size, location and orientation.
PreView Shoulder is the first orthopedic software under the FDA's new QIH classification for artificial-intelligence-based products. It will be available to surgeons in the coming month.