FDA Okays MedCognetics’ Radiological Computer-Aided Triage and Notification Software

MedCognetics Inc. has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for CogNet AI-MT+, its enhanced artificial intelligence (AI)-enabled radiological computer-aided triage and notification software.

The device is cleared under 21 CFR 892.2080 (Radiological Computer Aided Triage and Notification Software), Class II, Product Code QFM. The FDA considered the device to be substantially equivalent to legally marketed predicate products, thus permitting its U.S. commercialization.

“This is a meaningful milestone for MedCognetics and reflects years of work developing AI tools designed to support radiologists in real-world clinical environments,” MedCognetics CEO Debasish “Ron” Nag said. “Delayed diagnoses cost lives. When radiologists are overwhelmed by volume, critical findings can slip through the cracks. Our mission has always been to build AI that performs reliably across diverse patient populations, while helping clinicians address workflow pressures that directly affect patient access, diagnostic timelines, and overall quality of care. That’s equity in action, not just principle.”

Radiology departments worldwide face rising imaging demand amid workforce constraints. Built on the MedCognetics CogNet AI-MT platform and developed to support earlier identification of potentially suspicious findings and a more efficient clinical workflow, CogNet AI-MT+ integrates into existing imaging and IT systems to support worklist prioritization. The software analyzes 3D mammography exams—also known as digital breast tomosynthesis (DBT)—and flags studies that may warrant prioritized review, helping radiology departments manage increasing imaging volumes while maintaining clinical vigilance. DBT produces a three-dimensional view of breast tissue and is widely used in screening and diagnostic workflows.

This latest clearance expands MedCognetics’ regulatory footprint in breast imaging AI. The company previously received FDA 510(k) clearance for its earlier-generation AI-enabled breast cancer screening software, marking its initial entry into FDA-cleared medical imaging solutions. CogNet AI-MT+ represents the next evolution of the company’s platform, extending its capabilities into radiological triage and notification workflows, according to the company.

MedCognetics has previously received support through the National Institutes of Health (NIH) AIM-AHEAD program, which advances artificial intelligence and machine learning approaches aimed at improving health equity and addressing disparities in care. This is reinforced by the company’s U.S. patent covering methodologies for inclusive, unbiased AI, supporting consistent performance across patient populations and more reliable mammography detection.

CogNet AI-MT is part of MedCognetics’ CogNet AI platform, designed to enhance radiologists’ capabilities by expanding insights and awareness in medical imaging. This unbiased platform, trained on a diverse global dataset, advances the performance of radiologists and imaging centers, delivering accurate care for patients worldwide. CogNet AI-MT employs advanced AI and machine learning to detect early signs of cancer across all ethnicities. The platform is FDA 510(k) cleared for triage of mammogram images.

MedCognetics provides an advanced AI software platform that integrates into the radiology workflow. In addition, the AI algorithm is trained on a diverse global patient dataset to mitigate data bias. The future of AI in healthcare is unbiased services, and MedCognetics is at the forefront of creating a more predictable medical outcome and ultimately saving lives. Founded in 2020, the company is based in Dallas, Texas. For more information, please visit our website at www.medcognetics.com.