Springbok Analytics, co-founded by University of Virginia biomedical engineering professors Silvia Salinas Blemker and Craig Meyer, has received 510(k) clearance from the FDA for its MuscleView™ AI technology.
MuscleView analyzes MRI data to produce 3D visualizations of musculature and provides detailed information on muscle health including individual muscle volume, left-right muscle asymmetry, bone volume and intramuscular fat percentage. This technology, developed from more than 13 years of research, makes precision medicine available across a wide range of sports medicine, orthopedics and therapeutic applications. The research that led to Springbok was funded in part by UVA’s Wallace H. Coulter Center for Translational Research.
“We are incredibly proud to be at the forefront of advancing the understanding of muscles and muscle health,” said Blemker. “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.”
The MuscleView AI was trained on a vast array of MRI scans, including scans from patients of different biological sex, age and ethnicity. The training scans also covered a range of MRI parameters such as manufacturer, magnetic field strength, field of view and scan resolution. The technology makes a manual, time intensive process automatic, precise and objective.
According to the FDA, the 510(k) classification is a premarket notification that requires a comprehensive review of safety and performance data for medical devices. Receiving approval means Springbok can commercialize its technology, bringing MuscleView’s targeted analysis to more people.