1COMA3 · PATIENT CLINICAL AI · SaMD CLASS IIA CERTIFIED · AEMPS / EU MDR 2017/745
Clinical guidance from real physicians. Not a chatbot.
1coma3 connects you with clinical protocols authored and signed by named specialist physicians — across 18 specialties, in your language, available 24/7. Certified as a medical device. Not trained on generic internet data.
Why 1coma3 is not a chatbot
SaMD Class IIa Certified
Same regulatory pathway as surgical devices and diagnostics. AEMPS certified under EU MDR 2017/745.
Physician Authored
Every protocol authored and signed by a named physician with 20-year agreements and royalties.
Your Data Is Protected
Your data is never used to train generic AI. Governed, consented, GDPR compliant.
Clinical Workflow
01
Protocol Input
Medical authored clinical knowledge.
02
AI Reasoning
Clinical reasoning enhanced by AI.
03
Governance Check
Policy and compliance validation.
04
Clinical Decision
Traceable medical decision output.
Clinical Disclaimer
1coma3 provides clinical orientation — not diagnosis or medical treatment. Always consult a qualified healthcare professional. In case of emergency, call 112 (EU) or 911 (US).
AEMPS SaMD Class IIa classification: verbal confirmation received March 2026. Written report expected Q2 2026. CE Marking in submission. AI Act Annex III high-risk AI system — conformity assessment initiated. 1coma3 does not hold FDA clearance or MHRA approval at this time.
Build the Future of Clinical Intelligence
1coma3 enables healthcare organizations to deploy governed clinical AI safely and transparently.
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