Boston, MA, November 29, 2021 - QMENTA announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its QMENTA Platform for Care. This 510(k) clearance enables suitably qualified physicians to use the platform to manage imaging and other data across a network via web and customized user interfaces, and process it by accessing and using integrated AI marketed applications for imaging analysis and reporting.

The Imaging AI Analyses Catalog hosts over 50 proprietary and industry gold-standard algorithms that provide objective biomarker and brain structure measurement and disease progression tracking for use in clinical studies. The catalog allows algorithms to be searched by disease focus, biomarker type and regulatory clearance status. In addition to this one-stop access to best-in-class algorithms, multiple point solutions are integrated and unified into disease-specific Biomarker Packages, initially launching for Alzheimer’s Disease, Multiple Sclerosis and Neuro-oncology, making the choice of optimal algorithms clear and simple.

QMENTA CEO Vesna Prchkovska has been named the GOLD Stevie® Award winner for Female Entrepreneur of the Year in the 18th annual Stevie Awards for Women in Business. QMENTA, the company she founded, has been named the winner of a SILVER Stevie® Award for Startup of the Year - Business Products Industries. QMENTA is a medical software solution and services company with deep expertise in medical imaging and neurology, whose AI-powered cloud platform empowers breakthroughs in Research, Clinical Trials, and Healthcare Delivery.