AI Solution That Analyzes Muscle Health from MR Images Nets FDA Clearance

Springbok Analytics announced that it has received FDA 510(k) Clearance for MuscleView, its AI-based muscle health analysis of MR images. Springbok's technology comprehensively measures musculoskeletal structures from a wide range of MR systems, strengths, and sequences, producing personalized 3D visualizations and analyses of muscle health including individual muscle volume, left-right muscle asymmetry, bone volume and intramuscular fat percentage.

"Achieving FDA 510(k) clearance is a significant milestone for our company and a true testament to the integrity, diligence and collaboration our entire team has brought to Springbok every day over the last several years," said Scott Magargee, CEO and Co-Founder of Springbok Analytics. "This clearance is a key pillar to our commercialization strategy, allowing us to further integrate MuscleView and our cutting-edge muscle analytics into sports medicine, orthopedics, and therapeutic applications."

Developed over more than 13 years of research and scientific validation, Springbok's AI technology transforms complex MRI data produced from rapid scan protocols into simple 3D visualizations of one's exact musculature, creating a new standard in muscle health. Springbok is providing a new way for life sciences, elite sports and human performance organizations to deliver precision medicine to the individual at scale.

"We are incredibly proud to be at the forefront of advancing the understanding of muscles and muscle health," said Silvia Blemker, Chief Scientific Officer and Co-Founder of Springbok Analytics. "Receiving FDA clearance is a significant validation of the technology we've dedicated years to developing and perfecting, leveraging advancements in AI and MRI technologies."

Springbok's MuscleView technology takes what used to be highly manual, time intensive, subjective, and susceptible to variability and makes it automated, objective, precise and reproducible. The AI responsible for muscle segmentation within MuscleView was trained and tested on MRI scans generated across varying patients, demographics (including biological sex, age and ethnicity), scan sites, and MRI parameters (including manufacturer, magnetic field strength, series settings/types, matrix size, field of view, and scan resolution).

"We envision a future where a Springbok scan becomes a routine part of annual health check-ups and an integral part of preventive health — with scans even more frequent depending on performance goals, injuries and recovery, or other health considerations," concluded Magargee. "Our goal is to empower individuals to better understand, monitor, and measure their muscle health across all stages of life."