Springbok Analytics, a life sciences muscle and analytics company, has received FDA 510(k) clearance for MuscleView, an AI-powered technology that analyzes muscle health via magnetic resonance (MR) images. 

The AI-based technology analyzes MRI data and produces personalized 3D visualizations and metrics of muscle health. 

Springbok Analytics' full-body muscle-analysis capabilities were introduced initially for research purposes in 2023.

According to Springbok, its technology was developed after more than 13 years of research and scientific validation.  

The aim of the AI technology is to alter complex magnetic resonance imaging (MRI) data produced from rapid scan protocols into simple 3D visualizations of someone's precise musculature thereby building a new standard in muscle health. 

In a statement, the company explained that AI accountable for muscle segmentation inside MuscleView was trained and tested on MRI scans generated across different patients, demographics as well as scan sites and MRI parameters such as 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," Scott Magargee, chief executive officer and cofounder of Springbok Analytics, said in a statement. 

"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."

THE LARGER TREND

In July, Immunis, a clinical-stage biotech company partnered with Springbok Analytics to build a new standard in muscle health with its MRI-based AI muscle analysis technology that is utilized in elite sports, human performance and life sciences.

Immunis is using Springbok’s technology to assess the effectiveness of its investigational secretome therapeutic, IMMUNA, in restoring muscle growth and function in a sarcopenic Phase 1/2a clinical trial population.

In June, Springbok Analytics announced its participation in a Phase 1 Clinical Trial to analyze safe dosage for clenbuterol that is used as a treatment for Facioscapulohumeral muscular dystrophy (FSHD). 

Springbok's MRI-based muscle analysis aids researchers in better understanding and identifying disease progression of FSHD by providing individual muscle volume and fat fraction metrics in clinical trial participants.