{"schemaVersion":"1.0","generatedFrom":"https://brightaifuture.com/discoveries/medcognetics-mammography-workflow","record":{"id":"medcognetics-mammography-workflow","headline":"Twelve millimetres, or three centimetres.","canonicalUrl":"https://brightaifuture.com/discoveries/medcognetics-mammography-workflow","datePublished":"2026-09-09","dateModified":"2026-09-12","sourcePublicationDate":"2025-12-11","author":null,"publisher":{"name":"Bright AI Future","url":"https://brightaifuture.com/"},"topics":["biology"],"summary":"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.","evidenceState":"Emerging","keyFacts":[{"label":"AI’s role","value":"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."},{"label":"Documented result","value":"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."},{"label":"Important limitation","value":"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."}],"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."],"evidenceLinks":[{"title":"FDA 510(k) clearance K252482 — CogNet AI-MT+ (MedCognetics)","url":"https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252482.pdf","type":"government"},{"title":"Metastatic presentation of breast cancer in India: evidence from the national cancer registry (2009–2020) · Lancet Regional Health SE Asia","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13092702/","type":"paper"},{"title":"Tumor size and detection in breast cancer: self-examination and clinical breast examination are at their limit · Cancer Detection and Prevention","url":"https://doi.org/10.1016/j.cdp.2008.04.002","type":"paper"},{"title":"Female cancer screening in India: uptake and inequality, NFHS-5","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11610822/","type":"paper"},{"title":"Community-based cancer screening at primary care level in Varanasi district · BMJ Open","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10729271/","type":"paper"},{"title":"AI-supported screen reading versus standard double reading (MASAI) · The Lancet","url":"https://www.thelancet.com/journals/landig/article/PIIS2589-7500(24)00267-X/fulltext","type":"paper"},{"title":"MedCognetics: mammography workflow","url":"https://www.medcognetics.com/","type":"institution"}],"evidencePackUrl":"https://brightaifuture.com/evidence-pack/medcognetics-mammography-workflow","embedUrl":"https://brightaifuture.com/embed/story/medcognetics-mammography-workflow","attribution":{"credit":"Bright AI Future","requirements":["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."],"sourceRights":"Linked source material, quotations, trademarks and media remain subject to their owners’ terms. No reuse right is granted for third-party media."}},"claim":{"humanProblem":"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.","priorConstraint":"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.","aiRole":"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.","documentedResult":"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.","whyItMayMatter":"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.","unresolvedQuestions":["What share of women flagged by these vans reach diagnosis and treatment?","Does an earlier stage at detection here translate into survival, and who will measure it?"]},"evidenceAssessment":{"state":"Emerging","claimConfidence":"unassessed","reviewState":"approved","reviewMethod":"ai-assisted","reviewNote":"Re-reported from primary sources in September 2026. The regulatory status comes from FDA clearance documents, the Indian epidemiology from the ICMR national registry and NFHS-5, and the detection-size contrast from a published hospital series. The deployment account is published by the participating companies and is not independent verification. Bright first encountered this work through material curated by NVIDIA; the 'lives saved' figure in that material appears in no source and is not repeated here.","lastSourceReview":"2026-09-12","independentVerification":"not-established-by-this-source-review"},"sources":[{"id":"source:fda-k252482","title":"FDA 510(k) clearance K252482 — CogNet AI-MT+ (MedCognetics)","url":"https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252482.pdf","type":"government"},{"id":"source:ncdir-hbcr-2026","title":"Metastatic presentation of breast cancer in India: evidence from the national cancer registry (2009–2020) · Lancet Regional Health SE Asia","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13092702/","type":"paper"},{"id":"source:guth-2008","title":"Tumor size and detection in breast cancer: self-examination and clinical breast examination are at their limit · Cancer Detection and Prevention","url":"https://doi.org/10.1016/j.cdp.2008.04.002","type":"paper"},{"id":"source:nfhs5-breast-exam","title":"Female cancer screening in India: uptake and inequality, NFHS-5","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11610822/","type":"paper"},{"id":"source:varanasi-followup-2023","title":"Community-based cancer screening at primary care level in Varanasi district · BMJ Open","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10729271/","type":"paper"},{"id":"source:masai-lancet","title":"AI-supported screen reading versus standard double reading (MASAI) · The Lancet","url":"https://www.thelancet.com/journals/landig/article/PIIS2589-7500(24)00267-X/fulltext","type":"paper"},{"id":"source:medcognetics-mammography-workflow","title":"MedCognetics: mammography workflow","url":"https://www.medcognetics.com/","type":"institution"}],"revisions":[{"id":"revision:d0731f2401c365d5e9ec","recordedAt":"2026-09-09","summary":"Added to Bright as a bounded source claim with visible evidence distinctions.","sourceIds":["source:medcognetics-mammography-workflow"]},{"id":"revision:medcog-2026-09-12","recordedAt":"2026-09-12","summary":"Re-reported around access and tumour size at detection, with the FDA-cleared indication, the Indian registry evidence and the follow-up drop-off made explicit. The supplied 'saved 24 lives' figure was traced to no source and is not carried.","sourceIds":["source:fda-k252482","source:ncdir-hbcr-2026","source:guth-2008","source:nfhs5-breast-exam","source:varanasi-followup-2023"]}],"corrections":[]}