The Hexoskin Medical System for Clinical Development

Continuous Physiology Between Every Study Visit

Clinic visits capture a moment. The Hexoskin Medical System records 3-lead ECG, breathing, activity, and sleep at home, day and night, so sponsors and CROs see how participants respond between visits, with the data, the platform, and the study services in one place. FDA 510(k) cleared for recording, displaying, and storing 3-lead ECG, heart rate, respiratory rate, and activity, and configurable for research measures such as heart rate variability, tidal volume, and sleep.

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Heart

3-lead ECG and heart rate, FDA-cleared. Heart rate variability for research.

Breathing

Respiratory rate, FDA-cleared. Tidal volume and minute ventilation for research.

Activity & Sleep

Activity, FDA-cleared. Steps, body position, and sleep for research.

Study Platform

Hexoskin OneView, the participant app with ePROs, and secure data hosting.

One Recording, Value Inside and Outside the Trial

Clinic visits capture a moment; most of a participant’s life happens between them. The Hexoskin Medical System records the heart, breathing, activity, and sleep at home, so the program sees how participants respond to treatment, day and night, and the same data supports real-world evidence after the trial. Hexoskin delivers it end to end: protocol support, equipment, Hexoskin OneView with ePROs, participant and site support, and analysis-ready data, scoped to the workstreams your program needs.

From Protocol to Report

Start-Up

Kick-off, protocol and consent review, and Hexoskin content for the ethics submission.

Materials and Training

Participant start-up guides and manuals in the study languages, and training sessions for site staff.

Platform Set-Up

Hexoskin OneView configured for sites, users, ePROs, and surveys in the participant app, with secure hosting and daily backups.

Equipment and Logistics

We select the equipment and accessories for the protocol and take care of logistics to sites and participants, with maintenance and replacements handled.

Participant and Site Support

Technical support for participants by phone, chat, and email, escalation to clinical application specialists, and compliance reporting.

Analysis and Close-Out

Data assessment, analysis plan, cleaned and annotated datasets, statistical analysis, final report, equipment return, and data transfer.

Explore Clinical Development Workstreams

The Hexoskin Medical System supports four workstreams in clinical development. Most programs start with one and add others as the study grows: data collection in the trial, biomarker and endpoint development, data and AI work, and full study delivery.

Clinical Trials & Study Data Collection

Continuous measures at home or across sites, with wear schedules, equipment, and support.

Explore Trial Data Collection

Biomarker & Measure Development

Find and specify the measures that move with the disease.

Explore Biomarkers

Data & AI Programs

Analysis-ready data, or analysis run with our data scientists.

Explore Data Science

Study Planning & Delivery Support

Equipment, platform, training, support, and analysis, end to end.

Explore Study Services

The Hexoskin Medical System

Woman wearing the white Hexoskin Medical System shirt with its front zipper

FDA 510(k) Cleared · Available for Research

Cardiorespiratory monitoring that patients wear like everyday clothing. The Hexoskin Medical System (HMS) records, displays, and stores 3-lead ECG, heart rate, respiratory rate, and activity, at home or in a healthcare facility, with textile sensors instead of adhesive electrodes.

For research, the HMS recorder and shirt can be configured to follow participants living with cardiovascular, respiratory, neurological, sleep, oncology, and rare conditions, day and night, with as little burden as possible.

Talk With Our Clinical Team Read the FDA 510(k) Summary

Designed for Continuous Wear

A front zipper, so the shirt goes on and comes off without being pulled over the head
Textile sensors located on the chest and the abdomen, with no adhesive electrodes on the skin
Light, soft fabric that stays comfortable through the day and the night, in men’s and women’s sizes
Recording starts when the recorder is connected, with up to 72 hours per charge and 600 hours of storage

What the FDA Clearance Covers

FDA 510(k) K243981, cleared November 18, 2025, Class II (21 CFR 870.2920)
Recording, display, and storage of 3-lead ECG, heart rate, respiratory rate, and activity
Used on the order of a licensed medical professional, for adult patients, as an aid to diagnosis and treatment
Three-lead ECG indicated for the manual assessment of cardiac rhythm disturbances

Available for Clinical Research

Three-lead ECG at 250 Hz and 16 bits, with heart rate, RR intervals, and heart rate variability
Dual-band respiratory inductance plethysmography at 125 Hz, with breathing rate, tidal volume, and minute ventilation
Three-axis accelerometer at 50 Hz, with activity, steps, cadence, and body position
Synchronization through Hexoskin OneApp or Hexoskin OneSync, and study management in Hexoskin OneView

The FDA clearance covers the recording, display, and storage of three-lead ECG, heart rate, respiratory rate, and activity in adults, as described in K243981. The research configuration and its derived measures are for research use and are not part of the clearance. HMS does not produce alarms, is not intended for real-time patient monitoring, does not provide automatic analysis or diagnosis, is not an apnea monitor, and is not intended for use with a pacemaker or as life-supporting equipment for critical care patients.

Talk With Our Clinical Team

Tell us about the protocol, the population, and the setting. Our clinical team will reply with the configuration, the measures, and the next step for your program.

Discuss Your Protocol Request a Clinical Quote

HMS Signals, Data Channels, and Metrics

Every output the Hexoskin Medical System records or computes. Select a card to read its unit and definition, filter by data group or measurement area, or search for a measure.

Hexoskin Medical System

Shirt and recorder for continuous cardiac, respiratory, and movement recording, with textile sensors and no adhesive electrodes.

HMS Shirt: ModelsMen’s and women’s
SensorsTextile
ECG Electrodes: LeadsThree
Sampling250 Hz
Resolution16 bits
Respiratory Inductance Plethysmography: BandsThoracic and abdominal
Sampling125 Hz
Accelerometer: AxesThree
Sampling50 Hz
Resolution0.004 g
Recorder: BatteryUp to 72 hours per charge
Storage600 hours

Data Group

Measurement Area

Raw Signals · CardiacFDA-Cleared Output

Three-Lead ECG

250 Hz · 16 bits · 1 µV resolutionContinuous

3 outputs with definitions

ECG Lead I (0.0064 mV): Electrocardiogram: Lead I ECG channel with a 16-bit resolution.
ECG Lead II (0.0064 mV): Electrocardiogram: Lead II ECG channel with a 16-bit resolution.
ECG Lead III (0.0064 mV): Electrocardiogram: Lead III ECG channel with a 16-bit resolution.

Data Channels · CardiacFDA-Cleared Output

Heart Rate

Beats per minute (bpm)Continuous

Heart rate: average over the last 16 heart beats.

Data Channels · CardiacResearch Output

RR Intervals

Seconds (s)Continuous

RR interval: time between two heart beat detections, calculated for every QRS event. Saved at the center of the QRS complex.

Data Channels · CardiacResearch Output

NN Intervals

Seconds (s)Continuous

NN interval: Time between two heart beat detections, calculated for every QRS event.

Data Channels · CardiacResearch Output

Energy Expenditure Estimate

Watts (W)Requires User Profile

Energy Expenditure Estimate: Total energy based on ECG, using the Mifflin and Keytel equation. Adjusted for the weight, height, sex, HRmax and HRmin of the user.

Data Channels · CardiacResearch Output

Heart Rate Variability (HRV)

Rolling 5-Minute Window

7 outputs with definitions

ANN (average NN interval) (Seconds (s)): Average of the valid RR intervals, calculated over the last 5 minutes.
SDNN (Seconds (s)): Standard deviation of the valid RR intervals, calculated over the last 5 minutes.
HRV_HF (Milliseconds squared (ms²)): HRV high-frequency power (HF = 0.15 to 0.40 Hz), calculated using the Lomb periodogram.
HRV_LF (Milliseconds squared (ms²)): HRV low-frequency power (LF = 0.04 to 0.15 Hz), calculated using the Lomb periodogram.
HRV_LF_normalized: HRV LF power normalized: LF / (LF + HF), where LF = 0.04 to 0.15 Hz and HF = 0.15 to 0.40 Hz.
HRV_triangular: HRV triangular index, calculated over the last 5 minutes.
NN_over_RR (NN/RR ratio): Ratio of valid NN intervals to all RR intervals over the last 5 minutes. Use as a quality score for the HRV results.

Signal Quality · CardiacResearch Output

Heart Rate Quality

Continuous

Heart rate status: quality of the heart rate signal.

Signal Quality · CardiacResearch Output

QRS Detection Quality

Continuous

QRS status: status of the last QRS detection.

Metrics · CardiacResearch Output

Heart Rate

Any Range or RecordMax Sprint Test5-Minute Rest Test

6 outputs with definitions

HR Avg (Beats per minute (bpm)): Average value of the heart rate (HR) for that range (activity) or record. Any Range or Record
HR Min (Beats per minute (bpm)): Minimum value of the heart rate (HR) for that range (activity) or record. Any Range or Record
HR Max (Beats per minute (bpm)): This metric does double duty depending on the context. On a range (activity) or record, it represents the maximum value of the heart rate (HR) for a given period. In a profile it represents the user's overall maximum heart rate. Any Range or RecordMax Sprint Test
HR Histogram (Beats per minute (bpm)): Histogram of the heart rate (HR) over time. Any Range or Record
Resting Heart Rate (Beats per minute (bpm)): Lowest heart rate value that is measured sitting down, when fully relaxed, without any distractions. Can be measured by completing the fitness test “5 minutes Rest Test” on Hexoskin OneApp. Otherwise, the default value will be attributed according to the user’s profile information (i.e. gender, age, etc.) 5-Minute Rest Test
Heart Rate Recovery (Beats per minute (bpm)): Reduction of heart rate (HR) after a fixed duration of recovery (1 minute) following a peak-intensity exercise. Max Sprint Test

Metrics · CardiacResearch Output

Heart Rate Variability (HRV)

5-Minute Rest TestAny Range or RecordDuring Sleep

13 outputs with definitions

RMSSD (Milliseconds (ms)): Root mean square of the successive differences. Time-domain measure reflecting the beat-to-beat variance in heart rate. 5-Minute Rest Test
AVNN (Seconds (s)): Average of the N-N intervals. Any Range or Record
SDNN (Seconds (s)): Standard deviation of all of the N-N intervals. Any Range or Record
ASDNN (Seconds (s)): Average of the standard deviations of all N-N intervals. Any Range or Record
SDANN (Seconds (s)): Standard deviation of the averages of the N-N intervals. Any Range or Record
Power NN (Milliseconds squared (ms²)): Total power, or variance, of the N-N intervals. Any Range or Record
Triangular Index: Integral of the density distribution (the number of all the N-N intervals) divided by the maximum of the density distribution. Any Range or Record
HRV (HF) (Percent (%)): Average value of HRV high-frequency power normalized. During Sleep
HRVHF Avg (Milliseconds squared (ms²)): Average value of HRV high-frequency power. During Sleep
HRVHF Norm Max (Percent (%)): Maximum value of HRV high-frequency power normalized. During Sleep
HRVHF Norm Min (Percent (%)): Minimum value of HRV high-frequency power normalized. During Sleep
HRVLF Avg (Milliseconds squared (ms²)): Average value of HRV low-frequency power. During Sleep
HRVLF Norm Avg (Percent (%)): Average value of HRV low-frequency power normalized. During Sleep

Metrics · CardiacResearch Output

Energy Expenditure

Requires User Profile

6 outputs with definitions

Energy (Kilocalories (kcal)): Total energy based on user-specific VO2, using the Mifflin and Keytel equation. VO2max, HRmax and HRmin are defined per user by the fitness tests; if the tests were not completed, defaults based on age and sex are used.
Energy Avg (Watts (W)): Average value of energy based on userSpec VO2. We used the Mifflin and Keytel equation where the VO2max, HRMax, HRMin are defined for each user.
Energy Min (Watts (W)): Minimum value of energy based on userSpec VO2. We used the Mifflin and Keytel equation where the VO2max, HRMax, HRMin are defined for each user.
Energy Max (Watts (W)): Maximum value of energy based on userSpec VO2. We used the Mifflin and Keytel equation where the VO2max, HRMax, HRMin are defined for each user.
Energy Histogram (Watts (W)): Histogram value of energy based on userSpec VO2. We used the Mifflin and Keytel equation where the VO2max, HRMax, HRMin are defined for each user.
Energy Total (Joules (J)): Total of energy based on userSpec VO2. We used the Mifflin and Keytel equation where the VO2max, HRMax, HRMin is defined for each user.

Raw Signals · RespiratoryResearch Output

Thoracic and Abdominal Respiration

Two breathing bands (RIP) · 125 HzContinuous

2 outputs with definitions

Thoracic RIP signal: Respiratory inductance plethysmography, thoracic band, sampled at 125 Hz with a 16-bit resolution.
Abdominal RIP signal: Respiratory inductance plethysmography, abdominal band, sampled at 125 Hz with a 16-bit resolution.

Data Channels · RespiratoryFDA-Cleared Output