Intersection cross-cut: sensor-ecg ∩ algo-afib-detection

Axes: sensors × algorithms

6 corpus entries disclose both tags.

Earliest disclosure: 2011-12

These entries are the direct inputs to OBVIOUSNESS_TEMPLATE.md. Any patent claim combining these two elements is anticipated or rendered obvious by the chain below.

FDA 510(k) K113862 (~2011) — iRhythm Zio Patch, long-term single-lead adhesive ECG monitor (2011-12)

  • id: fda-k113862-irhythm-zio-patch-2011
  • corpus: regulatory
  • form factor: patch
  • creator: U.S. Food and Drug Administration (CDRH); submitter iRhythm Technologies, Inc.
  • disclosure: U.S. FDA, 510(k) Premarket Notification K113862 (iRhythm Technologies, Inc., ‘Zio Patch’) — record at accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113862; a single-use adhesive chest patch recording a single channel of ECG continuously for up to ~14 days for later analysis, cleared as substantially equivalent to predicate ambulatory-ECG (Holter-class) devices. (Followed by a chain of subsequent iRhythm 510(k)s — e.g. K143513, K163512, K181502 — refining the device, the algorithm/ZEUS software, and the Zio AT mobile-cardiac-telemetry variant.)
  • ip status: regulatory-filing
  • sensors: sensor-ecg
  • algorithms: algo-arrhythmia-classification, algo-afib-detection
  • prior art notes: A public, dated FDA record of a single-use adhesive chest patch that records one channel of ECG continuously for up to ~14 days for later arrhythmia analysis — the modern ‘ECG patch’ realization of ambulatory ECG ([[holter-1961-ambulatory-ecg]]). Establishes as of ~2011 the public availability of an adhesive long-wear single-lead ECG patch with downstream automated arrhythmia analysis; and, as a 510(k), it cites a predicate chain back to earlier ambulatory-ECG devices — that chain is itself prior art. Prior art for ECG-patch claims; product-side and regulatory anchor for the patch × ECG cross-cut. Cf. [[apple-watch-series4-ecg-2018]] (the wrist single-lead route).

AliveCor Heart Monitor / KardiaMobile (2012) — smartphone-coupled single-lead ECG (2012-12)

  • id: alivecor-kardiamobile-2012
  • corpus: private
  • form factor: other
  • creator: AliveCor, Inc. (David Albert)
  • disclosure: AliveCor, Inc. ‘AliveCor Heart Monitor’ (later ‘KardiaMobile’), FDA-cleared December 2012 — a card-sized two-electrode module that records a single-lead ECG via dry electrodes touched by the fingers (or pressed to the chest) and streams it to a smartphone app for AF detection. (The ‘Kardia Band’ wrist-strap ECG accessory for Apple Watch followed in 2017, FDA cleared.)
  • ip status: patented
  • sensors: sensor-ecg
  • algorithms: algo-afib-detection, algo-arrhythmia-classification, algo-hr
  • prior art notes: Discloses a portable two-dry-electrode single-lead ECG recorder that the user contacts with the fingers (or chest) and that streams the trace to a smartphone for automated atrial-fibrillation detection — and, in the 2017 Kardia Band variant, the same dry-electrode single-lead ECG integrated into a wrist strap. Anticipates consumer single-lead-ECG and wrist-strap-ECG AF-detection claims from 2012/2017 — predating the Apple Watch Series 4 ECG (2018). Product-side anchor for the consumer-ECG cross-cut.

FDA De Novo DEN180044 (2018) — over-the-counter electrocardiograph software for use in detecting atrial fibrillation (Apple Watch ECG app) (2018-09-11)

  • id: fda-den180044-apple-watch-ecg-app-2018
  • corpus: regulatory
  • form factor: watch
  • creator: U.S. Food and Drug Administration (CDRH); requester Apple Inc.
  • disclosure: U.S. FDA, De Novo Classification Request DEN180044 (Apple Inc., ‘ECG App’), granted 11 September 2018 — decision summary at accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf; established a new FDA device classification for over-the-counter electrocardiograph software intended to acquire, store, transfer and display a single-lead (Lead I) ECG and to provide a rhythm classification (AFib vs. sinus rhythm) on a consumer wrist-worn platform, with general/special controls.
  • ip status: regulatory-filing
  • sensors: sensor-ecg
  • algorithms: algo-afib-detection, algo-arrhythmia-classification
  • prior art notes: A public, dated FDA decision describing — and creating the device class for — over-the-counter single-lead ECG software on a consumer wrist-worn device with on-device AFib-vs-sinus classification. As a government disclosure it establishes, as of 11 September 2018, the public availability of the device described: a wristworn Lead-I ECG with consumer-facing rhythm classification. Useful prior art for later claims to that combination; the De Novo decision summary also enumerates the clinical validation and the bench/algorithm characteristics, which are themselves citable. Pairs with the product entry [[apple-watch-series4-ecg-2018]] and the standard [[ieee-11073-10406-basic-ecg-2011]].

Apple Watch Series 4 (2018) — wrist single-lead ECG and PPG-based irregular-rhythm notification (2018-09-12)

  • id: apple-watch-series4-ecg-2018
  • corpus: private
  • form factor: watch
  • creator: Apple Inc.
  • disclosure: Apple Inc. ‘Apple Watch Series 4’, announced 12 September 2018 (ECG app and irregular rhythm notification feature enabled later in 2018) — a wristworn device taking a single-lead (Lead I) ECG between a back-crystal electrode and a Digital Crown electrode touched by the opposite hand, with on-device AF/sinus classification, plus a PPG-based irregular-rhythm (possible-AF) notification algorithm. FDA cleared via De Novo (ECG app: DEN180044; irregular rhythm notification: DEN180042).
  • ip status: patented
  • sensors: sensor-ecg, sensor-ppg
  • algorithms: algo-afib-detection, algo-arrhythmia-classification, algo-hr
  • prior art notes: Discloses a wristworn device that records a single-lead ECG between a watch-back electrode and a crown electrode touched by the contralateral hand, classifies the rhythm (AF vs. sinus) on-device, and separately runs a PPG-based background algorithm flagging possible atrial fibrillation. Anticipates wristworn-ECG and watch-AF-detection claims postdating September 2018; the underlying single-lead ECG and PPG-rhythm-screening techniques are much older ([[einthoven-1903-string-galvanometer-ecg]], [[holter-1961-ambulatory-ecg]], [[allen-2007-ppg-review]], [[ieee-11073-10406-basic-ecg-2011]]). Product-side anchor for the watch × ECG and watch × PPG × AF-detection cross-cuts.

Withings ScanWatch (2020) — hybrid analog watch with PPG, SpO2 pulse oximetry, single-lead ECG, and accelerometer (2020-01-05)

  • id: withings-scanwatch-2020
  • corpus: private
  • form factor: watch
  • creator: Withings SA
  • disclosure: Withings (Nokia/Withings). ‘ScanWatch’, announced January 2020 (CE-marked 2020; FDA cleared 2022) — a hybrid analog wristwatch integrating a reflectance-PPG sensor (heart rate, irregular-rhythm screening), an SpO2 (pulse-oximetry) measurement, a single-lead ECG (back electrode plus a bezel electrode touched by the opposite hand, with AF detection), a 3-axis accelerometer, and an altimeter — with sleep and activity tracking.
  • ip status: patented
  • sensors: sensor-ppg, sensor-spo2, sensor-ecg, sensor-accelerometer, sensor-barometer
  • algorithms: algo-hr, algo-spo2-estimation, algo-afib-detection, algo-arrhythmia-classification, algo-sleep-staging, algo-step-count, algo-respiratory-rate
  • prior art notes: Discloses a wristwatch combining reflectance-PPG heart rate, pulse-oximetry SpO2, a single-lead ECG with AF detection, accelerometry, and an altimeter, with sleep-apnea screening (from the SpO2/respiration signals) — multiple regulated cardiorespiratory measurements in one consumer watch. Anticipates multi-modal medical-smartwatch claims reciting combinations of wrist PPG-HR + wrist SpO2 + single-lead ECG from 2020. Product-side anchor for the watch × {PPG, SpO2, ECG} multi-sensor cross-cut.

Samsung Galaxy Watch3 / Samsung Health Monitor (2020) — wrist single-lead ECG and optical-PPG cuffless blood pressure (2020-08)

  • id: samsung-galaxy-watch-bp-ecg-2020
  • corpus: private
  • form factor: watch
  • creator: Samsung Electronics Co., Ltd.
  • disclosure: Samsung Electronics. ‘Samsung Health Monitor’ app on Galaxy Watch3 / Watch Active2, 2020 — wrist single-lead ECG (between a back-crystal electrode and a side-button electrode touched by the opposite hand, with AF/sinus classification) and a cuffless blood-pressure feature using the optical (PPG) pulse-wave signal calibrated against a periodic conventional cuff reading. (Cleared in Korea 2020; subsequently in other markets.)
  • ip status: patented
  • sensors: sensor-ecg, sensor-ppg, sensor-cuffless-bp-ptt
  • algorithms: algo-afib-detection, algo-arrhythmia-classification, algo-pwv-bp-estimation, algo-hr
  • prior art notes: Discloses a wristworn device that takes a single-lead ECG with on-device AF classification and, separately, estimates blood pressure from the wrist optical-PPG pulse waveform after calibration against a periodic conventional cuff measurement (a calibrated-cuffless approach). Anticipates wrist-cuffless-BP claims reciting ‘estimating blood pressure from a wrist photoplethysmography signal calibrated by a reference cuff reading’ from 2020 — the underlying PTT/PWV-BP technique is much older ([[geddes-1981-pulse-transit-time-bp]], [[mukkamala-2015-ptt-cuffless-bp-review]]). Product-side anchor for the watch × cuffless-BP cross-cut.

Public domain (CC0 1.0). The corpus IS the prior art commons.

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