FDA OKs Springbok Analytics’ MuscleView AI Muscle Health Analysis

Springbok Analytics has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for MuscleView, its artificial intelligence (AI)-based muscle analysis of magnetic resonance (MR) images.
 
The technology, according to the company, measures musculoskeletal structures from a range of MR systems, strengths, and sequences. It generates personalized, 3D visualizations and analyses of muscle health, including individual muscle volume, left-right muscle asymmetry, bone volume and intramuscular fat percentage.
 
Springbok’s AI technology was developed over more than 13 years of research and scientific validation, the company said. It transforms complex MRI data from rapid scan protocols into simple, 3D visualizations of exact musculature.
 
MuscleView takes a manual, time-intensive, subjective, and variable process and makes it automated, objective, precise, and reproducible. The AI for muscle segmentation was trained and tested on MRI scans from varying patients, demographics (biological sec, age, and ethnicity), scan sites, and MRI parameters (manufacturer, magnetic field strength, series settings/types, matrix size, field of view, and scan resolution).
 
“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.”
 
“We are incredibly proud to be at the forefront of advancing the understanding of muscles and muscle health,” added 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.”