Radiology AI cleared by FDA
Medcognetics' radiological AI triage software won FDA clearance to speed notification workflows, promising faster alerts for time‑sensitive imaging findings. (x.com)
The FDA’s 510(k) decision for CogNet AI‑MT+ is recorded as K252482 and the agency’s decision letter is dated December 11, 2025 under regulation 21 CFR 892.2080, Regulatory Class II, Product Code QFM. (accessdata.fda.gov) CogNet AI‑MT+ is cleared specifically to analyze digital breast tomosynthesis (DBT) exams and flag studies for prioritized review, enabling automated worklist triage that integrates with existing imaging and IT systems. (diagnosticimaging.com) The FDA decision letter shows MedCognetics validated the software with Hologic’s Selenia Dimensions system during design verification and explicitly states the firm may market the device subject to general controls. (accessdata.fda.gov) MedCognetics framed CogNet AI‑MT+ as an evolution of its earlier breast‑imaging product line after its prior FDA 510(k) clearance for QmTRIAGE, which the company announced in December 2022 as its initial FDA‑cleared breast cancer screening software. (appliedradiology.com) Company statements and the Newsfile press release note the platform was trained on a diverse global dataset and that the FDA found the device substantially equivalent to legally marketed predicate products, clearing the way for U.S. commercialization. (newsfilecorp.com) MedCognetics cited prior NIH AIM‑AHEAD support for its work on inclusive AI, and CEO Debasish “Ron” Nag has emphasized the company’s goal to reduce missed or delayed diagnoses amid rising imaging volumes. (mpo-mag.com)
