InMed AI Receives FDA 510(k) clearance for NeuroShield™

AI-powered NeuroShield automatically quantifies brain volumes using MRI data – the first of its kind with the capability to provide ethnicity-specific reference ranges.

CHICAGO, Nov. 13, 2023 /PRNewswire/ -- InMed.AI (InMed Prognostics Inc.), a pioneer in AI-driven predictive analytics using multi-modal data including text, signal, and image (US Patent No.11263749) and the creator of an end-to-end fully automated organ agnostic imaging platform, announced that it has received the US Food and Drug Administration (FDA) 510(k) clearance for NeuroShield™, a fully automated brain geometry-based quantifying analytics tool/cloud platform that uses AI/Deep Net/3D Convolutional Networks to support physicians as a clinical decision support tool for neurologists and neuroradiologists. NeuroShield is currently in clinical use in over 220+ sites across the world. In-Med is supported by seed funding from Sriram Natarajan, Founder & CEO of Molbio Diagnostics.

NeuroShield takes 3D MR images as inputs and automatically calculates brain volumes that can assist physicians in devising treatment plans for patients with neurodegenerative diseases such as Dementia, Alzheimer's' Disease, Parkinson's, and Epilepsy. The segmentation analysis revealed remarkable accuracy, reliability, and effectiveness of NeuroShield. A trial of 280 subjects drawn from different parts of the US demonstrated the product's high accuracy across scanners of different magnetic strengths, clinical subgroups, gender, age, slice thickness, and US geographic regions.

Globally, over a billion people suffer from neurodegenerative disorders. Even with recent promising pharmaceutical developments, treating neurodegenerative diseases depends on the timely identification of prospective candidates for early intervention who can benefit from this drug that extends their quality of life by several months to several years. Our peer-reviewed research shows that volumetry and atrophic changes can be detected as early as 42 years in females and 50 years in malesⁱ. NeuroShield volumetry tool can help detect atrophy early so patients can benefit from the newly discovered drugs.

In addition, it is recommended that patients using the new drugs undergo periodic scans to monitor for any side effectsⁱⁱ.  While Medicare will cover up to 80% of the cost of the drug, it also stipulates that only doctors who are willing to collect real-world performance data will be able to prescribe these medications, such as Lequembi. This will put pressure on the radiology fraternity, which is among the scarcest resources in most countries, including in the US. NeuroShield is an affordable solution that can assist by reducing radiologists' burden by automating MRI imaging analysis and support physicians by providing accurate and actionable results that can aid in clinical decision-making.

NeuroShield is also the first in the world to provide reference ranges that can be adjusted to age, gender, and ethnicity, setting new standards in healthcare and bringing us closer to precision medicine that is relevant for everyone, everywhere. In-Med Prognostics has long recognized the critical role of inclusion and ethnicity in healthcare and is leading the charge in developing solutions tailored to diverse patient populations. Their in-depth understanding of the nuances in ethnicity-specific healthcare equips them to address disparities and provide more equitable access to high-quality medical devices and services. The mission of the company from the outset has been to bring affordable, accessible, reliable, and state-of-the-art healthcare tools to everyone, everywhere.

Speaking about the FDA 510k clearance, Dr. Latha Poonamallee, In-Med's founder, says: "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."

References:

ⁱ JOSHI, J. Desai, D. R. Kulkarni, A. Sakegaonkar; (2019). Role of Volumetric Analysis in Correlation of Gender and Atrophy in Dementia in Clinical Practice. ECR 2019. Poster Number C-1745. https://dx.doi.org/10.26044/ecr2019/C-1745.

ⁱⁱ Cummings J, Apostolova L, Rabinovici GD, Atri A, Aisen P, Greenberg S, Hendrix S, Selkoe D, Weiner M, Petersen RC, Salloway S. Lecanemab: Appropriate Use Recommendations. J Prev Alzheimers Dis. 2023;10(3):362-377. doi: 10.14283/jpad.2023.30. PMID: 37357276; PMCID: PMC10313141.

About In-Med Prognostics, Inc.

In-Med Prognostics is a pioneer in AI-driven predictive analytics using multi-modal data, including text, signal, and image and the creator of an end-to-end fully automated organ agnostic imaging platform at work in over 220+ sites in India, Africa, and the Middle East. With deep expertise in developing, deploying, and managing fully automated image processing algorithms and pipelines using AI/ML, their capabilities also include building and deploying tools for remote site monitoring, providing both central and site-based access to medical imaging data, dynamic dashboards, and imaging data visualization at sites of care and clinical trials. They continue to expand the product suites in CT Brain applications, Whole Body MRI/video Wellness/Athletic solutions, and lesion solutions for pancreatic and liver cancer.

For media inquiries and partnerships, please contact: Sivakumar J Sharma @ [email protected] 

SOURCE InMed AI