DIAGNOS secures Health Canada licence for AI retinal analysis platform CARA

RegulationProduct / Tech
โดย GlobeNewswire·Read original
Summary · why it matters

Diagnos Inc. has received a Health Canada Medical Device Licence for its CARA System, authorizing commercialization of the AI-assisted retinal image analysis platform to Canadian optometrists. The Class II licence, granted on July 23, 2026, allows the company to fully deliver services to IRIS The Visual Group and execute its marketing strategy for the Canadian optometry market. CARA integrates five AI-powered modules—including detection of age-related macular degeneration and diabetic retinopathy, retinal microvascular analysis, image enhancement, and a clinician workspace—within a single workflow. The company is also pursuing regulatory clearances from the Saudi Arabia Food & Drug Authority and the United States Food and Drug Administration, with a U.S. submission targeted before the end of September 2026.

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Off-coverage companies 2

DIAGNOS Inc.Private▲ Positive
Regulationrelevance

Health Canada licence authorizes commercialization of CARA platform.

New Look Vision GroupPrivate± Mixed
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