{"id":"8ac24f8b-38e7-4011-bd9f-9b14d310c166","modelId":"66cc9543-ca9d-43c7-8dc5-02b2e6f95e04","versionId":null,"locationId":"aaf012fa-168b-4846-953c-a3295195aebc","operatorId":null,"ownerId":null,"slug":"pixel-watch-north-america","status":"operational","firstSeen":null,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://rover.report","title":"Rover registry backfill","date_accessed":"2026-06-07"}],"notes":"North American operational deployment. Pixel Watch operations.","keyFacts":[],"reviewNote":null,"exposureHours":null,"exposureBasis":null,"customerSegment":null,"scaleTier":null,"contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-06-08T01:08:00.085Z","updatedAt":"2026-06-08T01:08:00.085Z","model":{"id":"66cc9543-ca9d-43c7-8dc5-02b2e6f95e04","companyId":"0ed0d0e3-6e8b-4701-a812-f13221399dd4","modelName":"Pixel Watch","slug":"pixel-watch","description":"Pixel Watch (made by Google, part of Alphabet; current model the Pixel Watch 4 from October 9, 2025) is a biometric-primary smartwatch with cardiac AI augmentation, recorded in the new biometric form factor under a new Google company entity, with its health stack running on Fitbit and Google Health algorithms since Google owns Fitbit. Its standout FDA clearance is Loss of Pulse Detection, cleared on February 26, 2025 as the first feature of its kind, which detects a loss-of-pulse event such as cardiac arrest, respiratory or circulatory failure, or overdose and automatically prompts a call to emergency services if the user is unresponsive, alongside the Fitbit-lineage ECG app cleared in 2020 and atrial-fibrillation notifications cleared in 2022 carried into the Pixel Watch. A cap-flag applies because Loss of Pulse Detection is not a cardiac-monitoring or diagnostic feature and is explicitly excluded for users with preexisting heart conditions or those needing cardiac monitoring, with Google noting it may not detect every instance, so marketing it as general heart safety for cardiac patients exceeds the indication, and the cited 98.7-percent sensitivity and 100-percent specificity ECG figures are Google-reported algorithm performance. Fitbit, also Google-owned through its 2021 acquisition, is recorded as a separate registry entity, and the Fitbit app was rebranded to Google Health on May 7, 2026 with an optional $9.99-per-month premium tier gating a Gemini-powered AI coach. Its clinical-validation posture is growing, anchored by the large Fitbit Heart Study and Google's own loss-of-pulse validation but with lower independent peer-review volume than Apple, and the exact loss-of-pulse FDA submission number and whether the Pixel Watch 4 adds net-new clearances beyond inherited features are not verified.","formFactor":"biometric","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"FDA clearances","value":"Loss of Pulse Detection: FDA-cleared Feb 26 2025 - FIRST-of-its-kind; detects a loss-of-pulse event (cardiac arrest, respiratory/circulatory failure, overdose) and auto-prompts a 911 call if the user is unresponsive. ECG app (Fitbit lineage, cleared 2020) + AFib/irregular-rhythm (Fitbit, 2022) carried into Pixel Watch."},{"label":"CAP-FLAG","value":"Loss of Pulse Detection is NOT cardiac-monitoring/diagnostic and is EXPLICITLY excluded for users with preexisting heart conditions or needing cardiac monitoring ('may not detect every instance') - marketing it as general heart-safety for cardiac patients exceeds the indication. The ECG 98.7% sensitivity / 100% specificity figures are Google-reported algorithm performance (company-stated)."},{"label":"Entity note","value":"Recorded under a new 'google' company (Alphabet; consumer Pixel hardware). Fitbit (also Google-owned, acquired 2021) is a SEPARATE registry entity. Fitbit app rebranded to Google Health (May 7 2026)."},{"label":"Verification posture","value":"Boundary: biometric-primary + AI-augmented. Clinical posture: GROWING (Fitbit Heart Study ~455k participants; Loss-of-Pulse on Google's own validation; lower independent peer-review than Apple). NOT verified: exact FDA submission number for Loss of Pulse; whether PW4 adds net-new clearances beyond inherited PW3 features."},{"label":"Source/methodology (Phase 1A, 2026-06-04)","value":"Primary-FDA source added. Pathway cap-flag: Loss of Pulse Detection is on the FDA record as a 510(k) (K242967, substantially-equivalent), NOT a De Novo, though the loss-of-pulse DEVICE TYPE (product code SDY) was established via an earlier De Novo; some coverage frames it as De Novo. The accessdata 510(k) record is authoritative. Fitbit-lineage ECG/AFib on Pixel governed by K200948 (ECG) + K212372 (IRN)."}],"specs":"Pixel Watch (current: Pixel Watch 4, Oct 9 2025; PW3 supported). Sensors: multipath PPG optical HR, ECG (crown + caseback), SpO2, skin temperature, accelerometer; HRV, breathing rate, resting HR. Health stack runs on Fitbit/Google Health algorithms (Google owns Fitbit). Hardware purchase; Google Health Premium $9.99/mo optional (gates Sleep Profile + Gemini AI coach).","formFactor":"biometric (biometric-primary smartwatch + AI augmentation; loss-of-pulse / cardiac AI)","fda_clearance":{"source":"https://www.fda.gov/medical-devices/recently-approved-devices/fitbit-sense-ecg-k203204","status":"cleared","details":"Pixel Watch 1/2: FDA-cleared ECG via Fitbit integration (same K203204). Fall detection. NOT cleared for blood glucose or blood pressure.","audited_at":"2026-06-07","source_name":"FDA","health_claim":"ECG + fall detection via Fitbit algorithms. Wellness/fitness primary with FDA-cleared cardiac feature.","verification_posture":"verified"}},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://blog.google/feed/pixel-watch-3-loss-of-pulse-detection-fda/","title":"Pixel Watch Loss of Pulse Detection FDA-cleared (Feb 26 2025; excludes cardiac-condition users)","sourceName":"Google (blog)"},{"url":"https://www.engadget.com/wearables/pixel-watch-3-receives-fda-clearance-for-loss-of-pulse-detection-210458883.html","title":"Pixel Watch 3 FDA clearance for Loss of Pulse Detection (first smartwatch feature of its kind)","sourceName":"Engadget"},{"url":"https://blog.google/intl/en-au/products/devices-services/pixel-watch-4-design-upgrades-new-fitness-features-and-expanded-ai/","title":"Pixel Watch 4 released (Oct 9 2025; $349-$499)","sourceName":"Google (blog)"},{"url":"https://www.droid-life.com/2026/04/24/google-health-looking-like-fitbits-replacement/","title":"Google Health Premium ($9.99/mo, Gemini AI coaching); Fitbit app -> Google Health (May 2026)","sourceName":"Droid Life"},{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242967","title":"Pixel Watch Loss of Pulse Detection 510(k) K242967 (Feb 25 2025; applicant Fitbit/Google; product code SDY)","sourceName":"FDA 510(k)/De Novo Database"}],"aliases":["Pixel Watch","Pixel Watch 4","Google Pixel Watch"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"createdAt":"2026-06-03T22:31:07.786Z","updatedAt":"2026-06-07T14:07:42.476Z","company":{"id":"0ed0d0e3-6e8b-4701-a812-f13221399dd4","name":"Google","slug":"google","description":"Alphabet's consumer-hardware + software arm (Mountain View; NASDAQ: GOOGL) whose Pixel Watch is a biometric-primary smartwatch with FDA-cleared Loss of Pulse Detection + Fitbit-lineage cardiac AI.","status":"public (Alphabet; NASDAQ: GOOGL)","founded":1998,"hq":"Mountain View, California, USA","fundingTotal":null,"type":"both","reviewStatus":"reviewed","sources":[{"url":"https://blog.google/feed/pixel-watch-3-loss-of-pulse-detection-fda/","title":"Pixel Watch Loss of Pulse Detection FDA-cleared (Feb 26 2025; excludes cardiac-condition users)","sourceName":"Google (blog)"},{"url":"https://www.engadget.com/wearables/pixel-watch-3-receives-fda-clearance-for-loss-of-pulse-detection-210458883.html","title":"Pixel Watch 3 FDA clearance for Loss of Pulse Detection (first smartwatch feature of its kind)","sourceName":"Engadget"},{"url":"https://blog.google/intl/en-au/products/devices-services/pixel-watch-4-design-upgrades-new-fitness-features-and-expanded-ai/","title":"Pixel Watch 4 released (Oct 9 2025; $349-$499)","sourceName":"Google (blog)"},{"url":"https://www.droid-life.com/2026/04/24/google-health-looking-like-fitbits-replacement/","title":"Google Health Premium ($9.99/mo, Gemini AI coaching); Fitbit app -> Google Health (May 2026)","sourceName":"Droid Life"}],"keyFacts":[{"label":"Product","value":"Pixel Watch (PW4); Loss of Pulse Detection (FDA De Novo Feb 2025) + Fitbit ECG/AFib."},{"label":"Entity note","value":"Pixel Watch under 'google'; Fitbit (Google-owned) is a separate entity."},{"label":"wikipedia","value":"https://en.wikipedia.org/wiki/Google"},{"label":"wikidata","value":"https://www.wikidata.org/wiki/Q95"}],"aliases":["Google LLC","Alphabet","Pixel"],"collisionRisk":"low","reviewNote":null,"createdAt":"2026-06-03T22:31:07.026Z","updatedAt":"2026-06-03T23:26:19.997Z"}},"version":null,"location":{"id":"aaf012fa-168b-4846-953c-a3295195aebc","name":"North America","slug":"north-america","kind":"city","parentLocationId":null,"region":null,"lat":null,"lng":null,"reviewStatus":"unreviewed","aliases":[],"collisionRisk":"high","reviewNote":null,"createdAt":"2026-06-08T01:03:25.339Z","updatedAt":"2026-06-08T01:03:25.339Z"},"operator":null,"owner":null,"derived":{"trustTier":"unverified","currentPosture":null},"jsonLd":{"@context":"https://schema.org","@type":"Event","@id":"https://registry.deploy.report/deployments/pixel-watch-north-america","url":"https://registry.deploy.report/deployments/pixel-watch-north-america","name":"Pixel Watch at North America","identifier":"8ac24f8b-38e7-4011-bd9f-9b14d310c166","location":{"@type":"Place","@id":"https://registry.deploy.report/locations/north-america","name":"North America"},"organizer":{"@type":"Organization","@id":"https://registry.deploy.report/companies/google","name":"Google"},"about":{"@type":"Product","@id":"https://registry.deploy.report/models/pixel-watch","name":"Pixel Watch"},"publisher":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":"commercial","lifecycle_state":"active","architectural_position":{"cohort":"biometric","sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":[]}}}