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Clinical / medical-grade · Garment · by Hexoskin
Hexoskin Smart Shirt
A biometric garment recording ECG and breathing — now FDA-cleared (Medical System), with research-grade open data.
Nov 2025Hexoskin Medical System
Newly launched7 mo old
Consumer Smart Shirt since ~2013; the FDA-cleared Medical System is the clinical configuration.
API access: Yes — open Raw data access: Yes — open Open source: Community
Clinical value
74/100
FDA-cleared ECG + respiratory (Medical System)
Empowerment
76/100
Research API, raw signal export
Everyday value
44/100
A shirt — niche, must launder
A sensor-equipped garment that continuously records single-lead ECG and detailed breathing, with one of the deepest scientific validation records in wearables and a research-grade open data platform. Its Medical System configuration is now FDA-cleared for long-term ECG and respiratory monitoring.
What it measures
Continuous single-lead ECG, heart rate, breathing (respiratory rate, tidal volume, minute ventilation via thoracic and abdominal bands), and 3-axis activity, captured by a textile garment and recorder.
Regulatory status
The Hexoskin Medical System received FDA 510(k) clearance (Nov 2025) for long-term continuous ECG and respiratory monitoring in ambulatory patients. The consumer Smart Shirt is the research/wellness configuration of the same platform.
Validation & accuracy
Among the most validated wearables — used in 300+ peer-reviewed studies, with lab validation of HR and respiratory metrics at rest and during exercise.
Data control & export
Raw data: open — raw signal downloads, a research dashboard, and full data export. API: open — the Hexoskin Web API (OAuth, JSON) and SDK.
Wearability & battery
A washable biometric shirt plus a small recorder; comfortable for continuous wear but a garment you must launder and size, oriented to research and clinical use.
Cost & access
Garment/kit one-time (shirts ~$199–249; kits ~$849–899). App is free; the OneView research dashboard is ~$999/yr.
Who it serves
Researchers, clinical trials, and prosumers who want validated continuous ECG and respiratory data with open access.
Who is left out or burdened
A garment (laundering, sizing); research-oriented; the cleared Medical System targets clinical/trial deployment rather than casual consumers.
✓ Strengths
- FDA-cleared Medical System for long-term ECG + respiratory
- 300+ peer-reviewed validation studies
- Open research API, SDK, and raw signal export
- Continuous ECG and detailed breathing metrics
✕ Weaknesses
- A garment — laundering and sizing friction
- Research/clinical-oriented, not casual
- Research dashboard costs ~$999/yr
- Requires a recorder device
74
Why this clinical score. An FDA-cleared, heavily validated continuous ECG-and-respiratory platform is genuinely clinical — high on the axis; held below dedicated cardiac/CGM monitors because it targets research/trial deployment.
76
Why this empowerment score. A documented research API, raw signal downloads, and full export make it strongly empowering for data-minded users; the paid research dashboard is the main caveat.
44
Why this everyday score. As a laundered garment with a recorder it scores low on everyday wearability — powerful, but niche and high-friction for casual use.
Latest news
Reviews & coverage
Reviewers and researchers respect the lab-grade ECG, respiration and activity data captured from a comfortable garment. The barriers cited are high cost, the need to launder/charge a smart shirt and a research-oriented workflow.
Summary is a draft synthesis of public coverage, not an endorsement. Links open a search of each outlet.
Reddit communities
Independent user communities where this device (or its category) is discussed.
Get it · manuals & support
Draft profile · public-source review, June 2026 · scores describe direction and degree, not buying advice. News, links, and prices change — verify with the manufacturer. Image is representative.