Momentum Health receives FDA 510(k) Clearance for Momentum Spine Mobile App

After receiving their Health Canada Medical Device Establishment License, Momentum Spine continues to gain traction with FDA clearance and the launch of their mobile app.

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Momentum Health

We are excited to announce Momentum Spine has received U.S. Food and Drug Administration (FDA) 510(k) 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.

What is the Food and Drug Administration?

The Food and Drug Administration (FDA) is a vital regulatory agency tasked with ensuring the safety of the population in the United States. The FDA roles include watching over a variety of different products, including food, drugs, and medical devices. The FDA handles whether medical devices can be sold in the USA and whether they are safe for people to use.

Each device undergoes rigorous analysis in both safety and effectiveness of the potential product BEFORE they are allowed to be commercialized in the USA. The agency categorizes medical devices into different classes based on their level of risk, with Class III devices representing the highest risk and requiring the most stringent regulatory oversight.

What is FDA 510(k) Clearance?

Multiple application processes exist when applying for FDA Clearance. The 510(k) is one of many pathways. It involves proving that a medical device is substantially equivalent to legally marketed devices. The FDA determines whether it is considered as safe and effective as devices already approved.

What is Momentum Spine?

Scoliosis is the most prevalent spine deformity affecting 3% of children (1). It is estimated that 68% of adults above 60 years old will develop a spinal deformity (2). 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 breast cancer due to repetitive radiation exposure via X-Rays (3).

Momentum Spine is an AI-enabled digital health platform to remotely monitor postural asymmetries and spinal deformities, including scoliosis, from a simple video taken on a smartphone. The platform is used by clinicians and care teams to remotely monitor scoliosis patients without the radiation exposure and benefit from frequent follow-up. It is also available to the general population for self-monitoring of posture and spine health.

Key features and benefits of Momentum Spine

Innovative imaging: From a simple video taken on any mobile device, Momentum Spine reconstructs a 3D model of the torso that is true-to-scale, quantifiable and photorealistic.
Comprehensive analysis: The app provides real-time measurements such as shoulder symmetry, waist asymmetry, trunk shift, plumb shift and a detailed asymmetry map. The Cobb Angle is also predicted via artificial intelligence.
Designed for everyone: While primarily designed for patients suffering from spinal deformities like scoliosis, the app can also benefit the general population for monitoring posture and overall spine health.
Easy to use: Live, dynamic on-screen instructions guide you through the process to ensure the scan quality is optimal. Scoliosis resources and physiotherapy content are also provided to users.
Safety and effectiveness: Momentum Spine complies with all the relevant security, compliance, privacy and cybersecurity controls in Canada and the United States.

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, hospitals, and clinics, as well as make it available directly to consumers via app stores.

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!

DOWNLOAD NOW ON THE APP STORE (HERE) OR THE GOOGLE STORE (HERE)

**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.

Find Momentum Health on:

Instagram: @momentum.health.ai

Tiktok: @momentum_health

LinkedIn: Momentum Health

References:

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