MedPath

Springbok Analytics' MuscleView Receives FDA Clearance for AI-Powered Muscle Analysis

• Springbok Analytics has received FDA 510(k) clearance for MuscleView, an AI-powered technology analyzing muscle health through magnetic resonance (MR) images, enhancing precision medicine. • MuscleView transforms complex MRI data into 3D visualizations, providing detailed metrics like muscle volume and fat percentage, aiding in sports medicine, orthopedics, and therapeutic applications. • The AI within MuscleView was trained on diverse MRI scans, ensuring accuracy across different patients, demographics, and MRI parameters, automating and objectifying muscle health analysis. • This clearance allows Springbok to integrate MuscleView into clinical trials, such as those for Facioscapulohumeral muscular dystrophy (FSHD), to assess therapeutic effectiveness and disease progression.

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.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Clears AI Algorithm for Detecting Heart Failure with Digital Stethoscope

The FDA has cleared an AI algorithm developed by Eko Health and Mayo Clinic to detect heart failure using a digital stethoscope during physical exams.
The AI identifies low ejection fraction (EF), present in about 50% of heart failure cases, potentially enabling earlier diagnosis in primary care settings.

HeartBeam Submits FDA Application for 12-Lead ECG Synthesis Software

HeartBeam has submitted a 510(k) application to the FDA for its 12-lead ECG synthesis software, designed to assess various cardiac rhythms and arrhythmias.
The submission is supported by data from the VALID-ECG pivotal study, involving 198 patients across five clinical sites, demonstrating clinical equivalence to standard ECGs.

LifeSignals' UbiqVue 2A System Receives FDA Clearance for Continuous Wireless Patient Monitoring

LifeSignals' UbiqVue 2A system, featuring a wearable biosensor, has gained FDA 510(k) clearance for continuous remote patient monitoring in diverse settings.
The biosensor, worn on the chest, monitors 13 physiological parameters, including SpO2, ECG, respiration rate, and body temperature, transmitting data securely to a cloud-based system.

FDA Approves Landiolol (Rapiblyk) for Rapid Heart Rate Reduction in Critical Care

The FDA has approved landiolol (Rapiblyk) for short-term treatment of supraventricular tachycardia, including atrial fibrillation and atrial flutter, in critical care settings.
Landiolol, an intravenous adrenergic receptor antagonist, demonstrated a heart rate decrease within 10 minutes in up to 90% of patients in clinical trials.

FDA Clears AI-Powered Ultrasound Software EchoGo® Amyloidosis for Enhanced Cardiac Amyloidosis Detection

The FDA has cleared Ultromics' EchoGo® Amyloidosis, an AI-powered software, to improve early detection of cardiac amyloidosis.
EchoGo® Amyloidosis demonstrated high sensitivity (84.5%) and specificity (89.7%) in diagnosing cardiac amyloidosis in heart failure patients aged 65 and older.

BrightHeart's AI-Powered Prenatal Ultrasound Software Receives FDA Clearance

BrightHeart's AI software has received FDA 510(k) clearance for prenatal ultrasound evaluations of the fetal heart, aiding in the detection of congenital heart defects (CHDs).
The AI platform integrates into existing clinical workflows, automating key evaluation aspects to improve accuracy and save time for sonographers and OB/GYNs.

BrightHeart's AI Software Receives FDA Clearance for Fetal Heart Ultrasound Evaluations

BrightHeart's AI software has received FDA 510(k) clearance, enhancing the accuracy of detecting congenital heart defects (CHDs) during prenatal ultrasound exams.
The AI technology integrates into existing workflows, alleviating strain on sonographers and OB/GYNs by automating evaluation processes and improving diagnostic precision.

GE HealthCare's Signa Magnus Head-Only MRI Scanner Receives FDA Clearance

GE HealthCare's Signa Magnus, a head-only MRI scanner, has received 510(k) clearance from the U.S. Food and Drug Administration, facilitating its market entry.
The Signa Magnus system offers advanced clinical imaging and neuroscience capabilities, potentially improving the detection of various conditions affecting the head.

JLK Receives FDA Clearance for AI-Powered Stroke Diagnosis Solution JLK-PWI

JLK has secured FDA 510(k) clearance for JLK-PWI, an AI-based solution for analyzing brain MR perfusion images to detect brain infarction areas, marking their fourth FDA approval this year.
A study by Chonnam National University Hospital showed JLK-PWI had a significantly lower lesion detection failure rate (1.9%) in stroke patients compared to Rapid AI (61.4%).

AccurKardia and iCardio.ai Advance AI-Powered Cardiac Screening with FDA Designations

AccurKardia received FDA Breakthrough Device designation for its AI-driven ECG software designed to detect aortic valve stenosis (AVS) using existing ECG data.
iCardio.ai obtained FDA 510(k) clearance for its AI software, EchoMeasure, which automates echocardiographic interpretation and streamlines imaging workflows.

Reference News

[1]
Springbok Analytics receives FDA 510(k) clearance for MuscleView | MobiHealthNews
mobihealthnews.com · Oct 12, 2024

Springbok Analytics received FDA 510(k) clearance for MuscleView, an AI-powered technology analyzing muscle health via M...

[2]
UVA Biomedical Engineering Professor Receives FDA Clearance for AI Muscle Health Analysis Tool
engineering.virginia.edu · Oct 16, 2024

Springbok Analytics, co-founded by UVA professors Silvia Salinas Blemker and Craig Meyer, received FDA 510(k) clearance ...

[3]
Springbok Analytics Receives FDA 510(k) Clearance For MuscleView™, its AI Muscle ...
biospace.com · Oct 9, 2024

Springbok Analytics received FDA 510(k) clearance for MuscleView™, its AI-based muscle health analysis from MR images, e...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy