NSite Medical, a leader in scoliosis care and treatment, is excited to announce the FDA clearance of its innovative AI-based Scoliosis Assessment Application. This technological breakthrough signifies a major advancement in scoliosis diagnosis and management, reinforcing our commitment to cutting-edge scoliosis treatment.

This newly FDA-cleared AI-based Scoliosis Assessment App is a revolutionary tool designed to transform the management and treatment of scoliosis, and is the core technology that powers the National Scoliosis Clinic. This app provides an evaluation of the user’s presence or absence, and severity, of the curvature of their spine, without exposure to ionizing radiation with standard X-rays. By integrating advanced AI technology, the app analyzes critical aspects of scoliosis, offering users and healthcare professionals a detailed view of the current state of the condition. This enables the formulation of timely and effective action plans, tailored to each individual’s unique spinal profile and symptoms. The app’s ability to deliver precise and personalized insights ensures that users can take informed steps towards managing their scoliosis, improving their quality of life, and optimizing treatment outcomes.

Co-Founder & CEO Michael J. Gardner, MD said, “We are ecstatic about the FDA’s recent confirmation of the safety and efficacy of our AI-based scoliosis scanning app. This will have an immediate impact on scoliosis management pathways for patients, pediatricians, orthopedic surgeons and physical therapists. 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.”

Kevon Saber, Head of Business Development at NSite, shared, “As a scoliosis patient who wasn’t diagnosed until my 40s, I know firsthand that most scoliosis patients are not diagnosed or treated in a timely fashion. This gap leads to increased spine curvature and countless subsequent problems, including adult back pain that most adults experience. Our mobile app leverages cutting-edge AI to democratize care, putting it directly into the hands of anyone with a smartphone.” 

Steve Avila, MBA, Director of Operations, also noted, “Achieving FDA approval allows our company to bring this novel AI-based software to patients and providers enabling them to identify scoliosis early with the goal of preventing complex and costly surgeries. We’re excited to partner with healthcare systems and begin delivering results for their patients.”

Co-founder and inventor, Malcolm DeBaun MD, says “As someone who has witnessed our company’s growth from its inception, I am deeply proud of this milestone. Achieving FDA clearance is a testament to the hard work and innovative spirit of our team.”