DEPLOYDatabase

Company

Apple

Consumer-electronics company (Cupertino CA; NASDAQ: AAPL) whose [Apple Watch](/models/apple-watch) is a biometric-primary smartwatch with FDA-cleared…

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Founded
1976
HQ
Cupertino, California, USA
Status
public (NASDAQ: AAPL)

Models

1

Deployments

1

Overview

Consumer-electronics company (Cupertino CA; NASDAQ: AAPL) whose Apple Watch is a biometric-primary smartwatch with FDA-cleared cardiac/sleep AI (ECG, AFib, sleep apnea, hypertension notifications).

Verified record

Verified deployments
1 deployment on file
Active incidents
1 incident on file

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Key facts

Product

Apple Watch (Series 11 / Ultra 3); ECG + AFib + sleep apnea + hypertension notifications (FDA-cleared).

Exemplar

SpO2 disabled US (Masimo, Jan 2024) -> re-enabled Aug 2025 via redesign (computed on iPhone).

Data & sources

News coverage

1

Web sources

3

4 sources backing this record.View all →

Current platform

Apple Watch

Apple Watch (made by Apple Inc., Cupertino; current models the Series 11 and Ultra 3 from September 2025) is a biometric-primary smartwatch with FDA-cleared cardiac and sleep AI augmentation, sitting in the new biometric form factor distinct from the AI-primary wearable cohort because it would exist as a watch and biometric tracker without its AI layer, only degraded. Its FDA clearances are the verification anchor: the ECG app and Irregular Rhythm Notification were cleared via FDA De Novo in November 2018, AFib History via a 510(k) in June 2022 but only for users 22 and older already diagnosed with atrial fibrillation, sleep-apnea notifications via a 510(k) in September 2024 for moderate-to-severe obstructive sleep apnea in adults without an existing diagnosis and explicitly not for diagnosis, and hypertension notifications cleared in September 2025 as a 30-day passive screening tool rather than blood-pressure measurement. Marketing that frames AFib History as detecting new atrial fibrillation, or the sleep-apnea and hypertension features as diagnostic or as blood-pressure monitoring, exceeds the cleared indications and is cap-flagged. The blood-oxygen feature is a load-bearing verified-versus-claimed exemplar: it was disabled on US units from January 17, 2024 after the Masimo International Trade Commission import ban, then re-enabled on August 14, 2025 through a redesign in which the watch sensor captures raw data but the oxygen value is computed on the paired iPhone and shown in the Health app, so the sensor capability never changed while the legal and computation pathway did. Apple's clinical-validation posture is substantial, the highest peer-review volume in the cohort, anchored by the Stanford Apple Heart Study and large FDA submission studies, while the final Masimo legal end-state and whether the redesigned blood-oxygen reading matches the original accuracy are not verified.

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Relationships

Explainers

Plain-language answers to the questions people ask about Apple, from DEPLOY’s explainer library. Each is written in the language of the question and cross-checked against this registry.

  • What is Apple Watch?

    Apple Watch is the broadest installed-base biometric wearable in the cohort. Current product line: Apple Watch Series 10 + Apple Watch Ultra 2 + Apple Watch SE. Apple Watch operates the substantial-cleared FDA posture archetype: ECG/AFib De Novo 2018 (first consumer wearable ECG clearance), sleep apnea detection 2024, hypertension detection 2025. Purchase-only business model; no required subscription. Substantial peer-reviewed cardiologist validation (largest published study base in cohort). The Masimo blood-oxygen ITC ruling January 2024 → August 2025 redesign re-enable is a within-entity verified-vs-claimed exemplar.

Current leadership (1)

Former / Previously (2)

  • Jaime Waydo Chief engineer, autonomous systemssecondary-verified
  • Garrett Bastable Product operations (Apple Watch launch)secondary-verified

Safety record

1 incident on record (1 serious). Most recent: Jan 2024.

serious
1

Most recent: Jan 2024

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Full safety record: incidents, sourcing, and exposure data →

Incidents affecting Apple (1)

Includes incidents linked directly to this company, to its models, or to deployments of its models or under its operation. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Operated deployments (1)

Operator customers (1)

Recent coverage

Apple in third-party press

Peer companies