Lung Sound Analysis for Clinical Trials

FDA 510(k) Cleared | CE Mark (Biosensor only)

The RESP® Biosensor enables life sciences teams to objectively measure respiratory symptoms and physiological signals in daily life, providing greater insight into treatment response and differentiation across clinical programs.

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FDA 510(k)

Class II Cleared

RESP® Biosensor

CE Mark

European Conformity

RESP® Biosensor

ISO 13485

Certified

Quality management system

Clinically

Validated

Equivalent to electronic stethoscopes¹

HIPAA

Compliant

Privacy-preserving by design

RESP® Biosensor Inspiration

From Stethoscope to Sensor

Traditional stethoscope auscultation has been a gold standard for assessing respiratory health for over 200 years, with lung sounds such as cough, wheeze, rhonchi, or crackles indicating blockage and other problems in the airways. However, it is limited to episodic, in-person visits.

As we developed a solution to improve the management of chronic respiratory diseases, we designed the RESP® Biosensor to continuously capture lung sounds, extending the reach of stethoscope auscultation and providing clinical and research teams with insight into respiratory health anytime, anywhere.

Traditional Auscultation

Episodic, in-person visits only
Clinician-dependent, subjective assessment
No continuous overnight monitoring
Limited to scheduled appointment windows
No remote data capture

RESP® Biosensor

Continuous capture anytime, anywhere
Objective, algorithmic event detection
24/7 monitoring including sleep
Real-world, daily-life data
Automated cloud data transfer

Technology Overview

The RESP® Biosensor, often described as the 'Holter monitor for the lungs', is designed to continuously capture high-fidelity cough, lung sounds, and physiological measures to provide greater insight into respiratory status from anywhere, anytime. Clinically validated with equivalent performance to standard electronic stethoscopes.¹

Patient-Friendly

Wireless, discreet form factor and privacy-preserving — designed for comfortable multi-day wear without disrupting daily life.

Multi-Parameter and Device

Comprehensive respiratory and physiological measures that matter to patients, captured passively across the full monitoring period.

Validated Reporting

Automated or manual (human) overread to meet endpoint requirements. Comprehensive reports prepared by the Strados Labs team.

¹ M. Glass, et al. Results of Clinical Performance Testing of a Novel Wearable e-Stethoscope in Patients with Chronic Lung Diseases [abstract]. Am J Respir Crit Care Med

Strados Intelligence Advantage

Comprehensive respiratory insights with built-in sensor fusion

The RESP® Biosensor combines advanced acoustic monitoring with an integrated inertial measurement unit to capture lung sounds alongside chest wall movement, respiratory rate, and activity levels. Every event is processed through our proprietary CoughCheck™ algorithm and reviewed by trained human analysts — combining the scale of automation with the precision of expert oversight to produce regulatory-grade endpoint data.

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Metrics at a Glance

2M+

Lung Sounds Captured

60M+

Breaths Captured

Continents

Countries

Languages

243

Sites

RESP® Biosensor Measures

A robust combination of measures that reflect how patients feel and function. Onboard inertial measurement unit (IMU) allows for physiological insights alongside cough and lung sounds.

Cough Frequency (24-hour)
Cough Bouts
Cough Sound Intensity
Wheeze, Rhonchi, Crackles
Breathing Patterns*
Respiratory Rate*
Heart Rate & Heart Rate Variability*
Orientation (e.g. Supine or Upright)*
Sleep/Wake*
Activity Levels*

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

Digital Measures

Digital Measures for Multiple Indications

Indication	Cough	Wheeze	Crackles	Rhonchi	Resp. Rate*	Heart Rate*	Activity*
Chronic Cough
Pulmonary Fibrosis
Bronchiectasis
COPD
Asthma
Infectious Diseases
Lung Cancer
Congestive Heart Failure

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

Clinical Rationale

Why Include Lung Sounds as Endpoints?

Cough and lung sound abnormalities are among the most clinically meaningful — yet historically unmeasured — patient experiences in respiratory disease. The RESP® Biosensor makes them quantifiable, continuous, and regulatory-ready.

Lung sound spectrograms showing wheeze, crackles, and rhonchi

Improve insight into how patients feel and function, strengthening evidence to regulatory agencies

Reduce reliance on questionnaires to demonstrate treatment effect on symptoms

Differentiate your asset in a competitive marketplace

Uncover signals that may point to new or expanded indications

Identify new pharmacologic insights into your treatment

Features & Specifications

Device Specifications

Form factor	Wireless and discreet
Wear experience	Patient-friendly form factor
Monitoring mode	Continuous
Battery life	24+ hour
Water resistance	Water resistant
Power	Rechargeable
Dimensions	Height 3.3" Width 2" Depth .39"
Weight	100g
Privacy	HIPAA compliant, data at rest encrypted, data in transit encrypted
Clearances	FDA 510(k) Class II; CE Mark