Springbok Analytics has received the US Food and Drug Administration (FDA) 510(k) approval for MuscleView, its AI-powered technology for muscle health analysis of MR images.

The company designed the MuscleView technology to measure the musculoskeletal structures from a wide range of MR systems, strengths, and sequences.

It produces personalised 3D visualisations and analyses of muscle health, including individual muscle volume, left-right muscle asymmetry, bone volume and intramuscular fat percentage.

Springbok Analytics CEO and co-founder Scott Magargee said: “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.

“This clearance is a key pillar to our commercialisation strategy, allowing us to further integrate MuscleView and our cutting-edge muscle analytics into sports medicine, orthopaedics, and therapeutic applications.

“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.”

Springbok has developed the AI-powered muscle health analysis technology based on more than 13 years of research and scientific validation.

The technology is designed to translate complex MRI data produced from rapid scan protocols into simple 3D visualisations of the patient’s exact musculature.

It transforms a process that was previously manual, time-intensive, and subjective, into an automated, objective, precise, and reproducible solution, said Springbok.

The AI within MuscleView, responsible for muscle segmentation, was trained and validated on MRI scans from different patients, considering a wide variety of factors.

The factors include biological sex, age, ethnicity, scan sites, and MRI parameters, such as manufacturer, magnetic field strength, matrix size, field of view, and scan resolution.

Springbok Analytics chief scientific officer and co-founder Silvia Blemker said: “We are incredibly proud to be at the forefront of advancing the understanding of muscles and muscle health.

“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.”