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InMed AI Receives First-of-Its-Kind FDA 510(k) Clearance for NeuroShield™

InMed.AI, an innovative leader in AI-driven predictive analytics utilizing diverse data modalities such as text, signal, and image, has announced the successful acquisition of FDA 510(k) clearance for NeuroShield™. This advanced tool and cloud platform, renowned for its pioneering use of AI, Deep Net, and 3D Convolutional Networks, introduces a groundbreaking approach to brain geometry-based quantifying analytics. Serving as a clinical decision support tool for neurologists and neuroradiologists, NeuroShield is currently operational in over 220 sites worldwide.

Tailored to analyze 3D MR images, NeuroShield offers automated calculations of brain volumes, providing crucial support for physicians in devising treatment plans for patients with neurodegenerative conditions such as Dementia, Alzheimer's Disease, Parkinson's, and Epilepsy. Extensive segmentation analysis has underscored the tool's exceptional precision, reliability, and effectiveness. Considering that over a billion people globally suffer from neurodegenerative disorders, the timely identification of candidates for early intervention becomes imperative, especially with recent strides in pharmaceuticals. Regular scans are recommended for patients using these novel drugs to monitor potential side effects.

While Medicare covers a significant portion of drug costs, it imposes the condition that physicians collecting real-world performance data can prescribe specific medications like Lequembi. This places additional responsibility on the already strained resource of radiologists, particularly in the US. NeuroShield emerges as an economically viable solution, alleviating the workload on radiologists by automating MRI imaging analysis and empowering physicians with accurate results for informed clinical decision-making.

NeuroShield stands out as the world's inaugural platform to furnish reference ranges adaptable to age, gender, and ethnicity, thereby setting novel standards in healthcare and advancing precision medicine suitable for diverse populations. In-Med Prognostics, committed to acknowledging the critical role of inclusion and ethnicity in healthcare, spearheads the creation of solutions tailored to diverse patient populations. The company's overarching mission is centered on making cutting-edge, affordable, and accessible healthcare tools available to individuals globally.

https://www.prnewswire.com/news-releases/inmed-ai-receives-fda-510k-clearance-for-neuroshield-301985705.html

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