Bright key facts / Emerging
Twelve millimetres, or three centimetres.
A breast cancer found by imaging is typically about 12 mm across. One found by a hand — a woman's own, or a clinician's — is typically about 21 mm. In India, where almost no one is screened, four out of five recorded tumours are already 3 cm or larger when they are found.
- AI’s role
- MedCognetics' cleared software does one narrow thing: it flags an exam so that suspicious studies rise in the radiologist's reading queue. FDA cleared it for triage and worklist prioritization only. It does not mark lesions, does not remove a study from the queue, and must not be relied on to make or confirm a diagnosis. A radiologist still reads everything.
- Documented result
- MedCognetics holds two FDA 510(k) clearances for mammography triage: K220080, cleared 29 September 2022, and K252482, cleared 11 December 2025. NVIDIA reported in October 2025 that the software runs on mobile screening vans operated by Health Within Reach in India, and that more than 3,500 women had been screened; that account is the companies' own.
- Important limitation
- The screening numbers and any account of lives saved come from the participating companies. No independent evaluation, audit or named patient exists, and early detection is not the same as a life saved.