Momentum Health receives FDA 510K Clearance for Momentum Spine, a Pioneering AI-Enabled Mobile Application for Monitoring Scoliosis, Available for Download Now!
After receiving their Health Canada class 1 medical device clearance, Momentum Spine continues to gain traction with FDA clearance and the launch of their mobile app.
MONTREAL, Feb. 15, 2024 /CNW/ - Momentum Health Inc. is excited to announce that its innovative mobile application, Momentum Spine, has received U.S. Food and Drug Administration (FDA) clearance. This state-of-the-art AI application offers a non-invasive, radiation-free solution to quantify postural asymmetries, including scoliosis, directly targeting a long-standing challenge in managing spinal deformities.
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Scoliosis is the most prevalent spine deformity affecting 3% of Children 1 and an estimated 68% of adults above 60 years old 2. It is defined as a sideways curvature of the spine in the coronal plane. The key to successful scoliosis management is early detection and frequent monitoring. However, in our current standard of care scoliosis patients are at elevated risks of cancer due to repetitive radiation exposure via X-Rays 3.
Momentum Spine is an AI-enabled digital health platform to remotely monitor postural asymmetries, including scoliosis, using a simple video taken on a smartphone. The platform can be used by clinicians and care teams to remotely monitor scoliosis patients with less radiation exposure and more continuous follow-up as well as the general population who would like to monitor their spine health.
LEARN MORE ABOUT MOMENTUM SPINE
With the recent FDA clearance, Momentum Health is progressing to the commercialization phase for the Momentum Spine technology. The company will offer their solution to health systems through institutional licenses and also make it available directly to consumers via app stores.
- Innovative Imaging: Using a simple video taken on a mobile device, Momentum Spine reconstructs a 3D model of the torso, leveraging 3D imaging and AI to quantify asymmetry.
- Comprehensive Analysis: The app provides real-time measurements such as shoulder symmetry, waist asymmetry, trunk shift, plumb shift, a detailed asymmetry map and will soon include AI-predicted Cobb Angle measurements.
- Designed for Everyone: While primarily designed for patients suffering from postural deformities like scoliosis, the app can also benefit the general population by monitoring overall spinal health.
- Usability: Usability validation testing under simulated-use conditions showed that both healthcare professionals and lay users can effectively use the app. All participants were able to perform the critical task of capturing videos in both standing and bent-over positions.
- Safety and Effectiveness: The technology and methods of Momentum Spine have undergone rigorous software verification and validation testing, ensuring its safety and effectiveness.
Dr. Jean Ouellet, a Pediatric Spine Surgeon and the Chief Medical Officer of Momentum Health Inc., shared his enthusiasm: "Receiving FDA clearance is a monumental achievement for Momentum Health. Momentum Spine not only empowers patients and healthcare providers with accurate and timely data but also signifies a leap in harnessing AI for spine care."
Try it for yourself TODAY!
**Indications for Use:**
The Momentum Spine app is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles, and track curve progression related to postural asymmetries, including scoliosis. The application is available directly to lay users (Over-the-Counter) and may also be prescribed by physicians. It is designed for patients aged 8 years and older.
Momentum Health Inc., based in Montreal, QC, is committed to creating groundbreaking digital health solutions that enhance patient care, optimize healthcare resources and empower individuals to quarterback their health.
1- Mo, Fred, and Matthew E Cunningham. "Pediatric scoliosis." Current reviews in musculoskeletal medicine vol. 4,4 (2011): 175-82. doi:10.1007/s12178-011-9100-0 |
2- Konieczny, Markus Rafael et al. "Epidemiology of adolescent idiopathic scoliosis." Journal of children's orthopaedics vol. 7,1 (2013): 3-9. doi:10.1007/s11832-012-0457-4 |
3- Loughenbury, P. R., et al. "Estimated cumulative X-ray exposure and additional cancer risk during the evaluation and treatment of scoliosis in children and young people requiring surgery." Spine Deformity 9 (2021): 949-954. doi:10.1007/s43390-021-00314-6 |
SOURCE Momentum Health Inc.
For media inquiries, please contact: Philippe Miller, CEO of Momentum Health, Email: [email protected]
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