Apple Watch

The Apple Watch (current Series 11 and Ultra 3, September 2025; Series 9/10 and Ultra 2 supported) is a biometric-primary smartwatch and the canonical reference of the biometric cohort, with the broadest FDA-cleared portfolio: ECG and AFib/irregular-rhythm notifications (De Novo 2018), sleep-apnea notifications (2024), and hypertension notifications (2025), plus fall and crash detection and the Vitals app. Its sensors (optical PPG, electrical ECG, temperature, accelerometer/gyro, blood-oxygen) need no subscription for the FDA-cleared medical features. Pricing anchors at about $399 for the Series base (aluminum, GPS), with the Ultra around $799 and the SE around $249 (the SE lacks ECG). A within-entity verified-vs-claimed exemplar: blood-oxygen was disabled in the US in January 2024 over the Masimo ITC ruling and re-enabled in August 2025 via a paired-iPhone calculation redesign. DEPLOY holds the claims to the specific cleared indications: these are cleared features with defined scope, not a general cardiac or sleep diagnostic.

Readiness

Apple Watch is shipping now at $399-$799 (actual sale price), no capability claims are on file, the model has no verified field deployments in the registry, and no incidents are on record.

Availability

shipping-now

Shipping now.

see evidence →

Price honesty

actual-sale-price

One price on file: $399-$799 (actual sale price).

see evidence →

Capability honesty

no-claims

No reviewed capability claims on file for Apple Watch.

see evidence →

Real-world use

commercial

Maturity: commercial. No verified deployments in the registry.

see evidence →

Safety record

no-incidents

No incidents on record. No verified deployments either.

What it claims to do

No reviewed capability claims on file.

Price

• $399-$799actual sale price · Apple (Apple Watch) ↗ · as of 2025-09-09

Real-world use

No verified deployments on file for Apple Watch.

Safety record

No incidents on record. No verified deployments either, so the absence is uninformative.

Privacy

No privacy practices disclosed or on file for Apple Watch.

Specs

notes

[{"label":"FDA clearances (the verification anchor)","value":"ECG app + Irregular Rhythm Notification: FDA De Novo Nov 2018 (DEN180044/DEN180042). AFib History: 510(k) Jun 2022 - cleared ONLY for users 22+ ALREADY DIAGNOSED with AFib. Sleep Apnea Notifications: 510(k) Sept 2024 - mod-severe OSA, adults 18+, NOT diagnostic. Hypertension Notifications: cleared Sept 2025 (K250507) - 30-day passive screening, not BP measurement."},{"label":"CAP-FLAG (marketing beyond clearance)","value":"AFib History is diagnosed-users-only (framing it as detecting NEW AFib exceeds the indication). Sleep-apnea + hypertension features are NOTIFICATION/SCREENING tools, never diagnostic or BP-measurement - any 'blood pressure monitoring' or 'diagnosis' framing exceeds clearance."},{"label":"Disabled-feature exemplar (verified-vs-claimed)","value":"Blood Oxygen / SpO2 was DISABLED on US units from Jan 17 2024 after the Masimo ITC import ban, then RE-ENABLED Aug 14 2025 via a REDESIGN: the watch sensor captures raw data but the SpO2 value is now COMPUTED ON THE PAIRED iPhone (shown in the Health app Respiratory section). The sensor capability never changed; the legal/computation pathway did - a clean capability-present-but-regulatory-blocked exemplar."},{"label":"Verification posture","value":"Boundary: biometric-primary + AI-augmented (would exist without AI but degraded -> biometric, distinct from form_factor=wearable AI-primary). Clinical-validation posture: SUBSTANTIAL (Apple Heart Study/Stanford NEJM 2019; sleep apnea N=1,448; hypertension >100k participants) - highest peer-review volume of the cohort. NOT verified: final Masimo legal end-state (ongoing); whether redesigned SpO2 matches original accuracy (no published comparison)."}]

specs

Apple Watch (current: Series 11 + Ultra 3, Sept 2025; Series 9/10 + Ultra 2 supported). Sensors: optical (PPG) HR, electrical ECG, temperature, accelerometer/gyro, blood-oxygen. AI/health: ECG app, AFib/irregular-rhythm notifications, AFib History, fall + crash detection, Vitals, sleep-apnea notifications, hypertension notifications. Hardware purchase; NO subscription for the FDA-cleared medical features.

formFactor

biometric (biometric-primary smartwatch + AI augmentation; FDA-cleared cardiac/sleep AI)

What's under the hood

No brain on file for Apple Watch.

Frequently asked questions

Is the Apple Watch actually available for purchase?

Yes, shipping now.Source: Apple Watch ECG app + Irregular Rhythm Notification via FDA De Novo (DEN180044/DEN180042, 2018)

What does the Apple Watch cost?

Apple Watch costs $399-$799 one-time (actual sale price).Source: Apple (Apple Watch)

Where is the Apple Watch being used?

No verified field deployments on record.

Is the Apple Watch safe?

No incidents on record, but with no verified field deployments either, the absence is uninformative.

How does the Apple Watch handle privacy?

No privacy practices disclosed or on file for Apple Watch.

Who makes the Apple Watch?

Apple Watch is made by Apple, based in Cupertino, California, USA.Source: Apple Watch ECG app + Irregular Rhythm Notification via FDA De Novo (DEN180044/DEN180042, 2018)

Compared to

• Steloby Dexcom · biometric
• Withings ScanWatchby Withings · biometric
• Fitbit (Charge / Sense / Versa)by Fitbit · biometric

Sources

1. Apple Watch ECG app + Irregular Rhythm Notification via FDA De Novo (DEN180044/DEN180042, 2018) · https://www.apple.com/newsroom/2018/12/ecg-app-and-irregular-heart-rhythm-notification-available-today-on-apple-watch/ ↗
2. Apple re-enables Blood Oxygen in US (Aug 14 2025; calculation moved to the paired iPhone) · https://www.apple.com/newsroom/2025/08/an-update-on-blood-oxygen-for-apple-watch-in-the-us/ ↗
3. FDA clears Apple Watch sleep-apnea notifications (Sept 2024; mod-severe OSA, 18+, not diagnostic) · https://www.cnbc.com/2024/09/16/fda-clears-apples-sleep-apnea-detection-feature-for-use-heres-how-it-works.html ↗
4. Apple Watch hypertension notifications FDA-cleared (Sept 2025; 30-day passive screening) · https://www.engadget.com/wearables/apple-watch-series-11-receives-fda-clearance-for-hypertension-alerts-120046138.html ↗
5. Apple (Apple Watch) · https://www.apple.com/apple-watch-series-11/ ↗ · 2025-09-09