Springbok Analytics, a life sciences company specializing in muscle analytics, has obtained FDA 510(k) clearance for its MuscleView technology. This AI-driven tool analyzes muscle health using magnetic resonance (MR) images, offering personalized 3D visualizations and detailed metrics. The clearance marks a significant step toward integrating advanced muscle analytics into various medical fields.
MuscleView: AI-Powered Muscle Analysis
MuscleView leverages AI to process MRI data, generating 3D visualizations of musculature and providing key information on muscle health. This includes individual muscle volume, left-right muscle asymmetry, bone volume, and intramuscular fat percentage. The technology aims to transform complex MRI data into accessible insights for healthcare professionals.
Scott Magargee, CEO and Co-Founder of Springbok Analytics, stated, "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." He added that this clearance is crucial for their commercialization strategy, enabling the integration of MuscleView into sports medicine, orthopedics, and therapeutic applications.
Development and Validation
Developed over 13 years of research, MuscleView's AI was trained and tested on a diverse range of MRI scans. This included scans from patients of different sexes, ages, ethnicities, and various MRI parameters such as manufacturer, magnetic field strength, and scan resolution. This extensive training ensures the technology's accuracy and reliability across different populations and settings.
Silvia Blemker, Chief Scientific Officer and Co-Founder of Springbok Analytics, noted, "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."
Applications and Future Directions
MuscleView is already being utilized in clinical trials. For instance, Immunis, a biotech company, 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. Additionally, Springbok is participating in a Phase 1 Clinical Trial to analyze safe dosage for clenbuterol 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. The company envisions MuscleView becoming a routine part of annual health check-ups, facilitating preventive health measures and personalized treatment plans.
