{"id":"51e9bf16-6d43-4ad4-87c9-eda4b2282ac5","slug":"regulatory-action-2026-06-15-happy-health","kind":"regulatory_action","headline":"Happy Ring earns second FDA clearance for at-home sleep testing","summary":"Happy Health received second FDA clearance for Happy Ring, now approved for at-home sleep testing. First FDA-cleared smart ring for multi-night sleep testing and 24/7 biometrics.","occurredAt":"2026-06-15T12:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"676e07ce-5d14-4b02-b991-3f3864e874f5","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"minor","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"other","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"createdAt":"2026-07-03T04:12:52.288Z","updatedAt":"2026-07-03T04:12:52.288Z","model":null,"deployment":null,"company":{"id":"676e07ce-5d14-4b02-b991-3f3864e874f5","name":"Happy Health","slug":"happy-health","description":"US health-wearables company (Austin TX) making the Happy Ring, a smart ring with two FDA 510(k) clearances for remote physiological monitoring and clinician-interpreted at-home sleep-disorder diagnosis; sold via the insurer-billed Happy Sleep home-sleep-test service.","status":"private ($60M Series A, Aug 2022, ARCH Venture Partners)","founded":null,"hq":"Austin, Texas, USA","fundingTotal":null,"type":"both","reviewStatus":"reviewed","sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242224","title":"FDA 510(k) K242224: Happy Ring Home Sleep Test (decision Jun 18 2025; facilitates at-home diagnosis of OSA/insomnia, ages 22+, under clinician direction)","sourceName":"FDA 510(k) database"},{"url":"https://aasm.org/fda-clears-happy-ring-by-happy-health/","title":"FDA clears Happy Ring (first clearance K240236, Oct 8 2024; retrospective remote monitoring of physiological parameters)","sourceName":"American Academy of Sleep Medicine"},{"url":"https://www.biospace.com/press-releases/happy-ring-earns-second-fda-clearance","title":"Happy Ring earns second FDA clearance (Home Sleep Test; sold via clinician-reviewed Happy Sleep home-sleep-test service; insurer-covered)","sourceName":"BioSpace / PRNewswire"}],"keyFacts":[{"label":"Product","value":"Happy Ring (FDA 510(k) K240236 monitoring + K242224 Home Sleep Test diagnosis support); sold via clinician-reviewed Happy Sleep service, insurer-billed."},{"label":"Editorial","value":"Genuinely-FDA-cleared sleep-apnea exemplar = verified counterpoint to RingConn's uncleared AHI."},{"label":"Company type","value":"US health-wearables company"},{"label":"Form factor","value":"Smart ring"},{"label":"FDA clearance indication","value":"Remote physiological monitoring"}],"aliases":["Happy Health Inc","Happy Ring","Happy Sleep"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-06-03T23:32:59.941Z","updatedAt":"2026-06-28T13:52:14.366Z"},"derived":{"status":"active"},"sources":[{"id":"cc5105cd-3873-477b-bce6-7e7b1f3ea735","incidentId":"51e9bf16-6d43-4ad4-87c9-eda4b2282ac5","url":"https://www.prnewswire.com/news-releases/happy-ring-earns-second-fda-clearancenow-approved-for-at-home-sleep-testing-to-simplify-the-diagnosis-and-treatment-of-sleep-apnea-and-related-health-conditions-302486269.html","label":null,"publishedAt":null,"notes":null,"title":"Happy Ring Earns Second FDA Clearance for At-Home Sleep Testing","sourceName":"PR Newswire","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-03T04:12:52.444Z","updatedAt":"2026-07-03T04:12:52.444Z"}],"responses":[],"statusEvents":[{"id":"f655c67d-7b52-4350-be41-ae2980bd879e","incidentId":"51e9bf16-6d43-4ad4-87c9-eda4b2282ac5","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-03T04:12:52.598Z","createdAt":"2026-07-03T04:12:52.599Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/regulatory-action-2026-06-15-happy-health","url":"https://registry.deploy.report/incidents/regulatory-action-2026-06-15-happy-health","headline":"Happy Ring earns second FDA clearance for at-home sleep testing","description":"Happy Health received second FDA clearance for Happy Ring, now approved for at-home sleep testing. First FDA-cleared smart ring for multi-night sleep testing and 24/7 biometrics.","identifier":"51e9bf16-6d43-4ad4-87c9-eda4b2282ac5","datePublished":"2026-06-15T12:00:00.000Z","articleSection":"regulatory action","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":[]}}}