InMed Prognostics Earns FDA Nod for NeuroShield Brain Volumetry Tool

InMed AI (InMed Prognostics), a company focused on artificial intelligence (AI)-driven predictive analytics, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for NeuroShield.
 
NeuroShield is an automated, brain geometry-based quantifying analytics tool/cloud platform that uses AI/Deep Net/3D Convolutional Networks as a clinical decision support tool for neurologists and neuroradiologists. The company said it’s currently in clinical use in over 220 sites around the world.
 
The technology takes 3D MR images as inputs, automatically calculating brain volumes to help clinicians devise treatment plans for dementia, Alzheimer’s disease, Parkinson’s and epilepsy. InMed said a 280-patient trial in the U.S. showed NeuroShield’s accuracy across scanners of different magnetic strengths, clinical subgroups, gender, age, slice thickness, and geographic regions.
 
The company’s research shows volumetry and atrophic changes can be detected as early as 42 years in females and 50 years in males, so the volumetry tool can help spot atrophy early for patients to benefit from newly discovered drugs. NeuroShield is also the first in the world, according to InMed, to provide reference ranges that can be adjusted to age, gender, and ethnicity.
 
InMed founder Dr. Latha Poonamallee told the press, “As a team, we continue to move forward propelled by our mission to bring affordable, accessible, reliable, and state-of-the-art healthcare tools to everyone everywhere. We believe that investing in healthcare is investing in our collective human future and that technology is a great lever to move towards precision health to extend quality of life. We will continue to be attentive to populations that are traditionally underserved and underrepresented both in the global north and south markets.”