FDA OKs GSI’s PreView 3D Shoulder Arthroplasty Planning Software

Genesis Software Innovations (GSI) obtained FDA clearance for its PreView 3D Shoulder Arthroplasty Planning Software, a tool for orthopedic surgeons to develop pre-op shoulder plans based on CT imaging studies. PreView software allows surgical planning with a representation of shoulder anatomy as a 3D model to digitally place the implant. Surgeons can optimize implant size, location, and orientation. The clearance is the first orthopedic solution under FDA’s new QIH classification for AI-based software solutions.
 
“We are incredibly excited about the FDA 510(k) clearance for PreView. We anticipate this to be the first of many announcements as our platform expands to include additional surgical applications throughout the anatomy,” Matt Miller, Senior Director, Technology Development for GSI told the press. “From its inception, GSI has built a strong team comprised of world-class surgeon designers, experienced medical managers and adept global engineers that were able to engage the vision of utilizing AI/Machine Learning (ML) algorithms and cutting edge gaming engine technology to produce a great baseline for the PreView platform of products. GSI believes in giving the best tools to surgeons for better outcomes for patients.  Importantly, we also engage the patient in this journey to gain insights into how to inform and improve the future of surgical outcomes.”
 
Nathan Estruth, Chairman of the Board at GSI said, “The PreView Shoulder platform was developed by an international team of experts including shoulder reconstruction specialists, artificial intelligence engineers and visual gaming programmers. This team effort has created a best-in-class product that performs automated computerized segmentation of CT scans, which allows surgeons to plan surgical cases when they want and where they want, without the need for external intervention to prepare the images for use. The 3D planning features are intuitive, which allow surgeons to quickly learn and utilize the software with minimal time to onboard. This is the first of many innovations in the pipeline for GSI.”
 
GSI’s platform aims to improve efficiencies, decrease costs, and improve outcomes and satisfaction. PreView software allows surgeons to make pre-op decisions regarding the type of surgery best suited for the patient’s condition while providing a literal PreView of what the surgeon will see in the operating room. This functional visualization brings more clarity to the surgery before entering the O.R., and it also reduces the total O.R. time, which is beneficial to patients, the surgical team, and the facility hosting the procedure. 
 
Miller said, “Our vision is to create great software tools that give medical professionals the information needed to produce consistently excellent surgical results.”