InMed secures FDA 510(k) approval for NeuroShield analytics tool
14 Nov 2023
NeuroShield is a cloud-based platform that captures 3D MR images using AI, Deep Net, and 3D Convolutional Networks to automatically calculate brain volumes, which help physicians create better treatment plans for patients with neurodegenerative diseases
InMed secures FDA approval for NeuroShield. (Credit: National Cancer InstituteCancer Institute on Unsplash)
InMed Prognostics has received the US Food and Drug Administration (FDA) 510(k) approval for its NeuroShield, a fully automated brain geometry-based quantifying analytics tool.
NeuroShield is a cloud-based platform that leverages AI, Deep Net, and 3D Convolutional Networks to support neurologists and neuroradiologists in making clinical decisions.
It works by capturing 3D MR images to automatically calculate the brain volumes, helping physicians create better treatment plans for patients with neurodegenerative diseases.
The neurodegenerative diseases may include Dementia, Alzheimer’s’ Disease, Parkinson’s Disease, and Epilepsy, among others.
NeuroShield is the world’s only generative AI-powered MR volumetric product that can provide reference ranges adjusted to age, gender and ethnicity, said InMed.
In-Med founder Latha Poonamallee said: “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.”
In a US clinical trial of 280 subjects, NeuroShield showed high accuracy across scanners of different magnetic strengths, subgroups, genders, ages, and geographic regions in the US.
Also, the segmentation analysis showed superior accuracy, reliability, and effectiveness of NeuroShield, which is currently being used in more than 220 sites across the world.
In-Med said that the volumetry and atrophic changes can be detected as early as 42 years in females and 50 years in males, according to its peer-reviewed research.
Its NeuroShield volumetry tool has the capability to help detect atrophy as early as patients can benefit from the newly discovered drugs.
It is also the world’s first tool to provide reference ranges that can be adjusted to age, gender, and ethnicity, bringing precision medicine closer to patients, said the medical device maker.
InMed is a provider of AI-powered predictive analytics using multi-modal data, including text, signal, and image and the creator of a fully automated organ-agnostic imaging platform.
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