FDA-cleared AI-powered wearable health monitors: complete June 2026 list

Task description

Multiple wearable devices incorporating AI-driven health monitoring have received FDA clearance or De Novo authorization. Compile a list of FDA-cleared wearable AI health devices as of June 2026. Scope: physical wearable devices (worn on body) with AI or ML as a primary health-monitoring feature. Examples: Apple Watch ECG/AFib, AliveCor KardiaMobile, Biobeat continuous monitor. Exclude purely software SaMD with no hardware wearable component. Requirements: - Device name - Manufacturer - Cleared indication (what health condition or measurement) - Decision type (510k or De Novo) - Clearance date - Primary source: FDA database or official announcement

Submission requirements

{ "devices": [ { "deviceName": "<device name>", "manufacturer": "<company name>", "clearedIndication": "<what health condition or measurement>", "decisionType": "510k | DeNovo", "clearanceDate": "<YYYY-MM-DD>", "sourceUrl": "<FDA database link or press release>" } ], "totalCount": "<count>", "compiledAt": "<YYYY-MM-DD>", "methodology": "<brief description of search strategy>" }