Genesis Software Innovations announced that it has received FDA clearance for its Preview 3D shoulder arthroplasty planning software.
This clearance is the first orthopedic solution under the FDA’s new QIH classification for software solutions based on artificial intelligence (AI).
Preview shows orthopedic surgeons a representation of the patient’s shoulder anatomy as a 3D model, allowing them to optimize implant size, location, and orientation by digitally placing the implant into the patient’s anatomy, according to the Grand Rapids, Mich.-based company. This functional visualization also reduces the total O.R. time, the company added.
“We anticipate this to be the first of many announcements as our platform expands to include additional surgical applications throughout the anatomy,” said GSI senior director of technology development Matt Miller in a news release.
The Preview software will be available in the coming month.