Digital Health
FDA 510(k) clearances, De Novo grants and premarket approvals, with software and AI-enabled devices tagged from FDA's own records.
openFDA publishes decisions only, so pending 510(k) and De Novo submissions are not shown, and no clearance chance is estimated.
Key numbers
AI-enabled devices (FDA list)
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Digital health devices
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De Novo grants
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Decisions, last 90 days
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Product Categories
Digital Health Products
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DTx-VCA: Digital Therapeutics Validation & Critical Appraisal
HealthTrade analysts score a device from its FDA decision and the pivotal ClinicalTrials.gov study an editor links. A score shows only once published, with its version and hash, and no clearance chance is ever estimated.
DTx-VCA domains
Total 100. A published score reads “Analyst DTx-VCA, Provisional” until a second reviewer adjudicates it (D-19).
Data provided by the U.S. Food and Drug Administration (openFDA, CC0). The digital health tag comes from FDA's own records: a software product code, the FDA regulation of a category, or FDA's Artificial Intelligence-Enabled Medical Devices list (opens in a new tab), which FDA updates a few times a year. Nothing here is investment advice.