FOR RESEARCH & CLINICAL TRIALS

RESP® Biosensor

Digital respiratory endpoints and cough monitoring for life sciences

FDA 510(k) Class II | CE Mark | HIPAA Compliant

Technology Overview

The RESP® Biosensor is a first-of-its-kind respiratory wearable developed to capture novel insights into treatment effects, including changes in cough frequency and lung sounds such as wheeze.

Patient-Friendly: A wireless, discreet form factor that respects patient comfort in daily life
Multi-Parameter: Collects a robust combination of respiratory and physiological measurements
Validated Reporting: Our qualified and trained annotation team ensures reporting meets endpoint requirements

RESP® Biosensor Measures

- - - - Cough Frequency (24-hour)
      - Cough Intensity* & Bouts
      - All Lung Sounds
      - Wheeze
      - Rhonchi
      - Crackles
      - Breathing Patterns & Respiratory Rate*
      - Heart Rate & Heart Rate Variability*
      - Orientation*
      - Sleep/Wake*
      - Activity Levels*

*Measurement not FDA cleared but may be collected in clinical trials

Trusted By

Metrics-at-a-Glance

1M+

Lung Sounds Captured

30M+

Breaths Captured

32

Countries

35

Languages

2

FDA 510(K) clearances

1

CE Mark

Why the RESP® Biosensor System?

Privacy & Security

Incorporates end-to-end encryption and speech obfuscation to preserve patient privacy

Accelerated Data Turnaround

Cloud-based, remote syncs streamline subject reporting and enable real-time adherence insights

High Fidelity & Integrity

Clinically validated, FDA 510(k) class II medical device that accurately collects data in real-world environments

Patient-Friendly

Wireless, discreet biosensor designed to integrate seamlessly into daily life

Multi-Dimensional Data

Collects a robust combination of respiratory and physiological data, all in one device

More Than a Cough Monitor

Using a combination of audio and motion data, the RESP Biosensor unlocks valuable insight across multiple indications, offering a more complete picture of subjects’ respiratory status and health-related quality of life alongside PROs.

	Cough	Wheeze	Crackles	Respiratory Rate*	Heart Rate*	Activity Level*	Orientation*
Chronic Cough
IPF
Bronchitis
COPD
Asthma
RSV
Covid-19
Heart Failure

Chronic Cough
IPF
Bronchitis
COPD
Asthma
RSV
Covid-19
Heart Failure

*Measurement not FDA cleared but may be collected in clinical trials

Flexible Reporting—Automated or Human Annotation

Strados Labs’ trained and qualified annotation team identifies and counts cough and lung sounds from subject recordings to meet primary endpoint requirements.

Our CoughCheck™ machine learning algorithm*, trained on over 200,000 coughs, has demonstrated strong accuracy in cough detection and is available for applications such as high-volume screening or exploratory endpoints.

*Algorithm not FDA-cleared but may be used in clinical trials

Visual spectrograms of lung sound events facilitate overread for trained annotators

Cough

Wheeze

Crackles

Patient-Friendly Form Factor

Unobtrusive, wireless form factor reduces patient burden in clinical trials.
3M Tegaderm dressing, gentle and breathable, is used to adhere biosensor to chest
Discreet design helps ensure patients behave naturally, capturing authentic symptom data that mirrors real-life conditions and minimizes the Hawthorne effect.

View Device Specifications

Publications

View our clinical validation, whitepapers and case studies

Cough Detection Performance of the CoughCheck Algorithm in Subjects with Subacute Cough

Poster Presentation, American Thoracic Society, 2025

Objective Cough Monitoring Detects More Patients with Cough Than Patient Self-Reporting

Poster Presentation, American Cough Conference, 2023

Results of Clinical Performance Testing in Chronic Lung Diseases

Poster Presentation, American Thoracic Society, 2022

View Latest Publications

Talk to our Team

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