HOLLAND, Mich., May 10th, 2021 – Shoulder Innovations (SI), an emerging leader in the development of shoulder replacement systems, announced today that it has signed an exclusive license agreement for Genesis Software Innovation‘s “GSI“ PreView Shoulder™ Arthroplasty Planning Software, which recently achieved FDA 510(k) clearance. This clearance is the first musculoskeletal solution under the FDA’s new QIH classification for software solutions based on Artificial Intelligence (AI).
GSI‘s PreView Shoulder™ software was developed by an international team of experts, including shoulder reconstruction surgeons, artificial intelligence experts, and visual gaming programmers. This team developed a best-in-class product that performs automated segmentation and reconstruction of imaging data, allowing surgeons to have functional visualization of their surgical cases prior to entering the operating room and without needing external data processing. Surgeons can optimize implant size, location and orientation by digitally placing the implant into the patient’s anatomy with a 3D view. This serves to improve the surgical experience by likely reducing total O.R. time and reducing risks, benefiting patients, surgical teams and facilities hosting the procedures.
Shoulder Innovations has a highly innovative, world-class product line for shoulder replacement, with numerous 510(k) clearances. The company is solving surgical challenges resulting in significant and tangible improvements in patients’ lives. Adding the PreView Shoulder™ software product to their shoulder surgery portfolio allows the company to bring greater clarity to the surgical process.
Dave Blue, Chief Commercial Officer for Shoulder Innovations said, “PreView Shoulder™ is extremely valuable because it helps surgeons who use this next-generation pre-operative planning software tool achieve precision and accuracy in complex total shoulder replacement surgeries. We are excited to offer our surgeons and their patients this valuable clarity, and there is no question that this is the next generation and thus really game-changing technology.”
Matt Ahearn, Shoulder Innovation’s COO said, “Shoulder Innovations is dedicated to improving efficiencies, decreasing costs and improving patient outcomes. SI has unmatched product innovation and therefore adding a unique breakthrough product such as PreView Shoulder™ fits perfectly into our strategy.”
Rob Ball, Chief Executive Officer of Shoulder Innovations, said, “Giving the best tools to surgeons results in better outcomes for patients. With our full platform of shoulder products and with the addition of the PreView Shoulder™ software, Shoulder Innovations is in a position to accelerate its impact on the shoulder replacement market.”
About Shoulder Innovations:
Shoulder Innovations Inc is a medical device development company that designs and commercializes innovative products which demonstrate the potential for improved patient care and reduced overall cost to the healthcare system.
Leveraging its breakthrough, patented, InSet™ glenoid design, Shoulder Innovations is commercializing a shoulder replacement implant system focused on improving outcomes related to the greatest cause of shoulder replacement failure: glenoid loosening.
The InSet™ technology has been shown in multiple peer reviewed publications to significantly reduce glenoid implant micro-motion and simplifies surgical the surgical technique, potentially reducing complications or increase implant longevity. Shoulder Innovations is based in Holland, Mich.
Learn more about Shoulder Innovations and its Total Shoulder Replacement System at shoulderinnovations.com.
Chief Commercial Officer, Shoulder Innovations