Genesis Software Innovations Gains FDA 510(k) Clearance For Preview 3D Shoulder Arthroplasty Planning Software

By Julie A. Vetalice

Genesis Software Innovations Gains FDA 510(k) Clearance For Preview 3D Shoulder Arthroplasty Planning Software

Genesis Software Innovations (GSI) received FDA 510(k) clearance to market PreView™, 3D shoulder replacement planning software based on CT imaging studies. PreView shows a representation of the patient's shoulder anatomy as a 3D model, allowing for digital placement of the implant and optimization of implant size, location and orientation. This clearance is the first orthopedic solution under FDA's new QIH classification for software solutions based on Artificial Intelligence.

PreView software will be available in the coming month.

GSI's platform is designed to improve efficiencies, decrease costs and improve patient outcomes and satisfaction. Its functional visualization brings clarity to the procedure before entering the O.R., and reduces total O.R. time.

Other tools in GSI's platform include:

  • GSI Recon Inventory™ to address inventory and sterilization for hospitals and surgery centers
  • GSI Insight™ for data collection and patient satisfaction
  • GSI Touch™ patient optimization software to assist in surgery preparation and recovery

"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," said Matt Miller, Senior Director, Technology Development for GSI.

Product Labels: Shoulder Replacement, Surgical Planning

Tags: 510(k) Clearance, Regulatory