The Withings Scan Monitor 2.0 is a smart scale device that records a two-channel electrocardiogram (ECG) when a user stands on it and holds a handle. It analyzes the ECG data using AI algorithms to detect normal rhythms and atrial fibrillation, and displays results on the device and a mobile app, helping patients and clinicians monitor heart conditions conveniently at home or clinical settings.
Intended Use
The Withings Scan Monitor 2.0 is intended to record, store and transfer lead II and lead-III of a two-channel electrocardiogram (ECG). In addition, it calculates and displays leads I, aVR, aVF, aVL. The device also displays ECG rhythms and detects the presence of atrial fibrillation when prescribed or used under physician care. Intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals in hospital, clinic, long-term care, and home environments.
Technology
The device is a smart scale with three stainless steel ECG electrodes that record lead II and lead III signals, and derives other leads (I, aVR, aVF, aVL). It uses ECG-SW1 AI algorithms to process and classify ECG waveforms for rhythm detection and atrial fibrillation identification. The device communicates wirelessly with a mobile app for displaying and managing data. It uses a 500Hz sampling rate and includes built-in feedback electrodes to reduce electromagnetic interference.
Performance
The device underwent non-clinical testing to IEC and ANSI/AAMI standards for electrical safety, biocompatibility, electromagnetic compatibility, and software verification. A human factors usability study confirmed that users accurately record ECGs and interpret results. An algorithm development used public datasets for training and validation on separate samples, preventing data leakage. A clinical multicenter study with 274 subjects showed high sensitivity (99%) and specificity (99%) for atrial fibrillation detection compared to a 12-lead ECG gold standard, demonstrating equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/24/2023
5 months - 2
FDA Approval
8/23/2023
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