BRIGHT EVIDENCE PACK / 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.

Canonical Bright record · JSON evidence pack · Key-facts embed

Dates and assessment

Source published: 2025-12-11
Bright published: 2026-09-09
Substantive update: 2026-09-12
Evidence state: Emerging
Independent verification: Not established by this source review
Last source review: 2026-09-12

The claim in context

The human problem

India has no organised breast screening programme. In NFHS-5, 0.9% of women aged 30 to 49 had ever had a clinical breast examination. The cancer is found late because nobody is looking early.

The prior constraint

Mammography needs a machine, a building and a radiologist. Rural districts have none of the three within reach, and a screening programme creates more images than the available radiologists can read.

AI’s actual 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.

The 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.

Why it may matter

Access, not cleverness, is the whole of this story. A van that reaches a district where 0.9% of women have ever been examined changes what stage the disease is found at — and stage is most of what survival depends on.

Limitations

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.
The cleared indication is triage only. It is not a diagnostic device, and its own labelling notes reduced performance for dense breasts and small lesions — common in the younger population it is deployed among.
The strongest trial evidence for AI in mammography, MASAI in Sweden, did not measure mortality and ran in a mature organised double-reading programme, a setting almost unlike rural India.
Screening only helps if treatment follows. In a documented Indian camp programme in Varanasi district, only 220 of 732 people who screened positive — 30.1% — completed follow-up, despite free transport and diagnostics.

Original evidence

Attribution

Credit Bright AI Future and link the canonical Bright record.

Link to the canonical Bright record.
Keep material limitations with the claim they qualify.
Link to the original evidence when repeating a substantive claim.
Do not describe a source check or organization-reported result as independent verification.

Linked source material, quotations, trademarks and media remain subject to their owners’ terms. No reuse right is granted for third-party media.