3D shoulder replacement planning software gets FDA approval

Genesis Software Innovations received 510(k) clearance from the FDA for its PreView Shoulder software for joint replacements.

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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.

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