Stage 5: regulator-cleared.
The rule that placed itA regulator has cleared or approved it for the task, where approval applies (for example the FDA for medical AI). Tasks no regulator covers are marked “No approval process exists”.
The evidenceThe FDA has cleared Transpara, ScreenPoint Medical's mammography AI, since 2018. Its latest clearance came in August 2026. FDA 510(k) K260898, Aug 14, 2026.
A stage says how far the evidence has got. It is not a rating of the AI and not advice.
- 1ClaimedNo evidence yet
- 2LaunchedNo evidence yet
- 3Independently testedNo evidence yet
- 4Tested with real peopleEvidence found
- 5Regulator-clearedPlaced here
- 6Widely used with a verified recordNo evidence yet
Everything we found.
In ladder order, newest first within each kind. Makers' own claims are labeled as theirs.
Tested with real people
- Randomized trial, over 100,000 women
In a randomized trial of over 100,000 Swedish women, AI-supported screening led to 12% fewer cancers diagnosed in the years after a screening.
“AI-supported mammography also reduces cancer diagnoses in the years following a breast cancer screening appointment by 12%”
MASAI trial · The Lancet, via ecancer · Jan 30, 2026
- Field study, 463,094 women, 119 radiologists · run with the maker
In Germany's national screening program, radiologists using AI found breast cancer at 6.7 per 1,000 women, 17.6% more than without it (5.7 per 1,000). The AI maker, Vara, was among the study's institutions.
“Radiologists in the AI-supported screening group achieved a breast cancer detection rate of 6.7 per 1,000”
PRAIM study · Nature Medicine, via University of Lübeck · Jan 7, 2025
Rules and approvals
- US · Approval · US Food and Drug Administration
The FDA has cleared Transpara, ScreenPoint Medical's mammography AI, since 2018. Its latest clearance came in August 2026.
FDA 510(k) K260898 · Aug 14, 2026
Not found in our sources yet: what the makers claim; what has launched; what independent tests found; how many people use it.
Track record and tools.
Failures and court cases are shown beside the stage, never folded into it. Tools are listed because the evidence names them, in no order of merit.
- TransparaScreenPoint Medical
- VaraVara (Vara MX Healthcare)
Can AI do these yet?
Answer my health questions
Stage 4 of 6Tested with real people
Randomized trial: chatbot users made no better health decisions
Check a mole for skin cancer
Stage 5 of 6Regulator-cleared
EU Class III CE mark lets DERM clear benign cases alone (company)
Be my therapist
Stage 4 of 6Tested with real people
Pilot trial: therapy chatbot did no better than ChatGPT on depression