NSite Medical earned FDA 510(k) clearance for its artificial intelligence-based Scoliosis Assessment Application, according to a Dec. 6 news release.
The app evaluates the presence or absence, and severity, of their spinal curvature without needing radation or x-rays. It can provide personalized insights using AI to help patients and physicians manage scoliosis and optimize treatments.
"This will have an immediate impact on scoliosis management pathways for patients, pediatricians, orthopedic surgeons and physical therapists," NSite Medical CEO Michael Gardner, MD, said in the release. "In addition to adolescents, 68% of adults over 60 have scoliosis, and this group will enjoy improved health outcomes with this technology and the National Scoliosis Clinic. This milestone is a significant initial step towards our mission of redesigning scoliosis care to be safer, more accessible and patient-centric.."