- The FDA has granted clearance for a new AI-based app that could help improve scoliosis assessments.
- The Scoliosis Assessment app uses a mobile device camera to scan a person’s back and provides an assessment of the back’s asymmetry.
- The app could potentially replace current assessment tools like scoliometers and visual assessments.
- The new technology could allow people to obtain earlier diagnosis and treatment, leading to better outcomes.
The Food and Drug Administration (FDA) has granted clearance for a new app assessing scoliosis, a condition affecting spinal curvature. NSite Medical, the National Scoliosis Clinic, developed the new Scoliosis Assessment app.
NSite co-founder and CEO Dr. Michael J. Gardner, a professor of Orthopaedic Surgery at Stanford University School of Medicine, said the new app could help healthcare professionals assess people with scoliosis or at risk for developing the condition.
Gardner explained that scoliosis is characterized by a curvature of the spine, which often presents during adolescence. The new technology has the potential to benefit children and adults alike.
Severe scoliosis can be disabling, which can negatively impact healthy lung function. While scoliosis can’t be cured, it can be treated with braces or surgery to prevent the curvature from worsening.
“The software application generates a 3D scan of the individual using a mobile device camera,” Gardner explained.
“Using the 3D scan, the application analyzes the asymmetry of the individual’s back surface and calculates an Asymmetry Index (AIx),” he added, noting that this is a quantitative measure of back asymmetry.
According to Gardner, the AIx can then be used to calculate the probability that a patient will develop scoliosis, which is clinically significant (having a Cobb angle>20 degrees).
“In several FDA trials, the device was found to be highly accurate in detecting scoliosis and estimating Cobb angle,” he noted.
Gardner added the app is designed to replace the traditional scoliometers and visual assessments in which a physician uses a protractor-like device to measure the degree of curving or examines the patient, looking for the telltale signs associated with the condition, such as body asymmetry or a visible curve in the spine.
Gardner noted that the app is an important advancement in scoliosis care because it allows for early accurate detection and fewer X-rays. The technology could also reduce the number of avoidable surgeries.
“The current methods of scoliosis screening are inaccurate and lead to many patients being diagnosed too late in their growth phase to benefit from nonsurgical interventions,” he explained. “These early interventions, like bracing and physical therapy, can reduce the progression of the spinal curvature.”
Gardner said the scoliometer test that’s currently used during assessments is “a rudimentary tool that has been unchanged for decades.”
He said the scoliometer is also prone to user error and false positive findings. Additionally, he said that many clinicians may perform a visual inspection, which could be even more prone to error.
“The NSite Scoliosis Assessment Application reduces user error and, with their proprietary AI algorithm, enhances the detection of scoliosis in the early stages of its development at the phase when the condition is responsive to nonsurgical treatment,” said Gardner, adding that the app does better at detecting scolosis and has fewer false positive and negative findings.
He said this will lead to earlier detection when nonsurgical treatments can still be effective, so fewer surgeries will be needed later.
Additionally, fewer false positives will mean fewer people need additional X-ray screening. The app can also be used in lieu of X-rays to monitor scoliosis over time, further reducing the patient’s exposure to radiation.
Dr. Kevin Huffman, DO, a doctor of osteopathy and CEO of On the Rocks Climbing Gym, said the new app was “groundbreaking.”
“The platform’s capacity to process complex data in real-time could significantly decrease errors inherent in manual measurement techniques and allow for a more standardized assessment method,” he told Healthline.
Huffman added that the app is a “tehnological leap,” especially when it comes to early diagnosis of scoliosis.
“[U]ntil now, we have depended on time-consuming physical exams and complex radiographic analysis,” he said. “The AI-based Scoliosis Assessment Application enhances our ability to make informed clinical decisions with heightened efficiency; it is a tool that transforms how we interpret data—a boon for practitioners and patients alike.”
According to Huffman, early diagnosis and intervention can potentially enhance treatment outcomes.
He said the new technology could streamline the process of monitoring and evaluating patients, and even reduce the burden on the healthcare system.
“The Scoliosis Assessment Application might not only spark further innovation but also herald a shift toward predictive analytics and personalized medicine,” Huffman said.
“I eagerly await the potential transformation of our scoliosis approach through this application—optimizing care pathways, bettering patient outcomes, and leading to tailored healthcare solutions.”
The FDA has granted clearance for NSite Medical’s AI-based Scoliosis Assessment Application.
The app can perform a 3D scan of a person’s back and measure the degree of asymmetry. It could replace current assessment tools like visual inspections and scoliometers that may be prone to error.
The new app is an important development since it will allow people to receive earlier treatment and avoid unnecessary surgery and X-rays, which could provide better outcomes for patients.