QMENTA announced 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 510(k) clearance (K202718) for the QMENTA Platform for Care (formally named The QMENTA Care Family Platform) is one of the more recently highlighted medical devices reviewed and authorized by the FDA in their tracking of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices.
Using the QMENTA Platform for Care, clinicians can simply and compliantly manage imaging data and apply marketed AI-enabled tools to visualize and gain quantified insights into features and changes in the brain. These marketed AI-enabled tools are hosted in the QMENTA Medical Imaging AI Analyses Catalog, a comprehensive set of over 50 marketed and research-only AI algorithms from verified, trusted scientific leaders focused on neurology. These world-leading AI algorithms and biomarker tools assist with quantification and analysis of disease onset and progression assessment, diagnosis and prognosis.
QMENTA CEO Vesna Prchkovska said, “FDA clearance for the QMENTA Care Platform is an exciting milestone for the industry, opening and democratizing access to the latest AI-powered imaging management and analysis tools.”