Strados Labs
Strados Labs builds FDA-cleared wearable respiratory biosensors (RESP®) and an integrated clinical-trial endpoint platform — including spirometry, FeNO, and eCOA — serving pharmaceutical sponsors, CROs, academic medical centers, and federal healthcare agencies.
- Company typePrivate
- Founded2018
- HeadquartersPhiladelphia, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Strados Labs does
Strados Labs is a medical technology company headquartered in Philadelphia, Pennsylvania, that develops FDA 510(k)-cleared wearable biosensors for continuous ambulatory respiratory monitoring. Founded in 2018, the company's flagship product is the RESP® Biosensor — a chest-mounted wearable device that continuously captures lung sounds in real-world and clinical trial settings. The platform is supported by the proprietary CoughCheck machine learning algorithm, trained on more than 200,000 coughs, which automates cough event detection and supports standardized respiratory endpoint generation. In March 2026, Strados acquired NuvoAir Clinical Trials, adding spirometry, fractional exhaled nitric oxide (FeNO), and electronic Clinical Outcome Assessment (eCOA) capabilities, transforming the company from a single-product biosensor vendor into an integrated respiratory clinical-trial endpoint platform.
The company's evidence base includes 87,000+ hours of collected respiratory data, 55+ clinical trials, 234+ investigator sites across 34+ countries, and 65+ peer-reviewed publications. The platform integrates with major clinical research technologies including Clario, Medidata Rave, Veeva Vault, and Trialogics, enabling deployment within enterprise-scale trial infrastructure. Strados holds two FDA 510(k) clearances (December 2020 and May 2022 for home use), CE Mark certification (November 2021), and ISO 13485 quality certification, supporting commercial activity in the United States, the European Union, and additional international markets.
Strados Labs operates a B2B enterprise business model targeting pharmaceutical sponsors, contract research organizations (CROs), academic medical centers, and federal healthcare agencies. Revenue is generated through hardware sales of the RESP® Biosensor, software subscriptions for analytics and endpoint services, and professional services including trial design and endpoint consulting. Distribution channels include direct enterprise sales, a strategic partnership with Clario, and federal procurement access via Lovell Government Services covering GSA, VA, and Defense Logistics Agency contracts. Named customers include Boehringer Ingelheim, Beth Israel Deaconess Medical Center, Jefferson Health, Rutgers/RWJBarnabas Health, and Lurie Children's Hospital, indicating a high-touch, quote-based enterprise sales motion rather than volume-based SMB distribution.
Strados Labs firmographics
Firmographics- Name
- Strados Labs
- Legal name
- Strados Labs, Inc.
- Website
- https://stradoslabs.com
- Company type
- Private
- Founded year
- 2018
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Strados Labs builds FDA-cleared wearable respiratory biosensors (RESP®) and an integrated clinical-trial endpoint platform — including spirometry, FeNO, and eCOA — serving pharmaceutical sponsors, CROs, academic medical centers, and federal healthcare agencies.
- Ownership category
- akta.pro rank
Strados Labs industry classification
Industry- Product category
- Digital Respiratory Endpoints for Clinical Trials
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Laboratory Analytical Instruments (3826), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Investigator & Site Training / GCP Support (HLAGACAF)
Keywords
Where Strados Labs is headquartered
LocationHeadquarters
- HQ city
- Philadelphia
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Strados Labs business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Infrastructure
Revenue model
- Device Sales and Rental: Sale and rental of FDA-cleared respiratory monitoring devices including RESP Biosensor, Air Next Spirometer, RESP Watch, and NObreath FeNO devices for use in clinical trials.
- Clinical Trial Services: End-to-end clinical trial services including device provisioning, global logistics, site training, expert overread, regulatory validation documentation, and endpoint strategy support. Revenue from Phase I-IV respiratory clinical trials across global sites.
- Software and Data Services: Cloud platform access, AI-powered analysis, automated quality checks, expert annotation, and regulatory-grade data reporting. Real-time dashboards and audit trail services.
Go-to-market motion3 records
Distribution channels5 records
Marketing channels6 records
Strados Labs product offering
Product offeringCore offering
Strados Labs provides an integrated respiratory endpoint suite for clinical trials, combining FDA 510(k) cleared wearable biosensors (RESP Biosensor, RESP Watch), spirometry (Air Next), FeNO (NObreath), and an eCOA platform with proprietary AI-driven cough and lung sound analysis. The company delivers device provisioning, global logistics, site training, expert human overread, and regulatory-grade data reporting for Phase I-IV respiratory clinical trials conducted by pharmaceutical sponsors and CROs.
Product overview
Strados Labs offers the Strados Endpoint Suite, an integrated respiratory endpoint platform for clinical trials that combines multiple measurement modalities under one platform. The suite includes the core RESP® Biosensor (FDA 510(k) cleared wearable for continuous cough and lung sound monitoring) and RESP® Watch (watch-based monitoring), complemented by acquired capabilities from NuvoAir including the Air Next Spirometer, NObreath® FeNO device, and eCOA platform. The platform delivers AI-powered analysis with CoughCheck™ algorithm, expert human overread, retained audio for regulatory audit, and unified data streaming across all endpoints for Phase I-IV respiratory clinical trials.
Differentiator
Problem solved
Functional benefit
Brands
- RESP® Biosensor: FDA 510(k) cleared wearable biosensor for continuous cough and lung sound monitoring
- RESP® Watch
- Air Next Spirometer
- NObreath® FeNO
- Strados eCOA
- Strados Endpoint Suite
Products and services
- RESP® Biosensor FDA 510(k) cleared wearable Class II medical device for continuous, multi-dimensional monitoring of cough and lung sounds. Captures high-fidelity audio along with respiratory rate, heart rate, and activity levels. Designed for use in clinical trials across respiratory indications including COPD, asthma, IPF, and cystic fibrosis.
- RESP® Watch Watch-based cough monitoring device using a familiar smartwatch form factor for low-burden, multi-day monitoring. Powered by the CoughCheck algorithm for automated cough detection with optional expert human overread. Built for clinical trial deployment.
- Air Next Spirometer FDA 510(k) cleared portable spirometer supporting FEV1, FVC, FEV1/FVC, PEF, FEF25-75% measurements. ATS/ERS 2005 and 2019 compliant. Supports both in-clinic and at-home monitoring with remote telehealth coaching platform.
- NObreath® FeNO Point-of-care fractional exhaled nitric oxide measurement device for rapid assessment of Type 2 airway inflammation. Compact, portable design for global trial site deployment.
- eCOA (Electronic Clinical Outcome Assessments) Digital platform for capturing patient-reported outcomes, symptom diaries, and quality-of-life instruments including SGRQ, ACQ, AQLQ, CAT, and E-RS. Includes ePRO, eClinRO, and eObsRO modules integrated with objective device data.
- Strados Endpoint Suite Integrated respiratory endpoint platform combining RESP Biosensor, RESP Watch, Air Next Spirometer, NObreath FeNO, and eCOA into a single solution for clinical trials. Features AI-powered analysis (CoughCheck algorithm), expert overread, retained audio for regulatory audit, and unified data stream across all endpoints for Phase I-IV respiratory clinical trials.
Quantifiable outcome
- More than 6 times as many abnormal events detected compared to episodic auscultation; over 97% accuracy in classifying wheezing and coughing compared to trained physician
- +2 more outcomes
Companies that use Strados Labs
Customer profileNamed customers7 records
Segments3 records
Ideal customer profiles4 records
Strados Labs technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability3 records
Feature6 records
Strados Labs partnerships and signals
Strategic signalPartnerships
Ten partnerships are on record, tiered core and strategic.
- NuvoAir Clinical TrialscoreAcquisition of NuvoAir's clinical trial business completed March 2026. Brings validated remote spirometry, FeNO measurement, and eCOA capabilities to Strados Endpoint Suite. Combined platform delivers full spectrum respiratory endpoints from single partner.
- Jefferson HealthstrategicSHORE study collaboration evaluating remote lung sound monitoring to predict COPD exacerbations following hospitalization. Study follows patients for 90 days after discharge using RESP Biosensor for continuous cough and lung sound monitoring.
- Rutgers Robert Wood Johnson Medical School / RWJBarnabas HealthstrategicResearch collaboration to evaluate RESP Biosensor in adult cystic fibrosis patients. Pilot study enrolling up to 100 participants to assess whether lung sounds correlate with disease severity and can serve as early indicators of health status changes.
- Beth Israel Deaconess Medical CenterstrategicResearch collaboration to evaluate RESP Biosensor for early detection of pulmonary edema in critically ill patients on mechanical ventilation. Single-center prospective observational study comparing biosensor data to conventional methods.
- TrialogicscorePartnership to leverage Trialogics' comprehensive logistical expertise to streamline the distribution and delivery of RESP Biosensors to clinical trial sites internationally. Trialogics provides clinical trial software and logistics services including device management and global logistics for clinical trials.
- Delve HealthcoreStrategic partnership to integrate Strados Labs' state-of-the-art technology into Delve Health's decentralized clinical trial platform. Enables drug developers to objectively and continuously measure respiratory symptoms such as cough and wheeze. Delve Health provides advanced remote monitoring capabilities and participant engagement automation.
- Digital Medicine Society (DiMe)strategicParticipation in DiMe's 'Building the Business Case for Digital Endpoints' project focused on advancing use of digital endpoints in clinical trials. Project develops ROI forecasting models and value frameworks to accelerate digital endpoint adoption.
- ClariocorePartnership to offer RESP Biosensor System to Clario's pharmaceutical and biotech customers for respiratory clinical trial endpoints. RESP Biosensor is the only FDA-cleared pulmonary wearable device for at-home capture of lung sounds. Integration enables Clario to support additional respiratory endpoints including cough and wheeze.
- Lovell Government ServicescoreLovell Government Services enables purchase of RESP Biosensor through federal contract vehicles including Defense Logistics Agency ECAT, VA Federal Supply Schedule, and GSA Advantage. Partnership enables streamlined procurement for government customers including VA hospitals and military medical facilities.
- Boehringer IngelheimcoreCollaboration to remotely monitor patients using RESP Biosensor in an idiopathic pulmonary fibrosis (IPF) pilot study. Boehringer Ingelheim uses the device to monitor cough and crackles in IPF patients at home to accelerate development of new therapies.
Scale indicators8 records
Recent moves8 records
Expansion highlights6 records
Strados Labs competitors and assessment
Company assessmentEmerging players
- Verily Life Sciences: Verily develops digital health tools and clinical trial endpoint technology including wearable sensors, competing for digital respiratory and multi-modal endpoint programs alongside Strados.
- Sanolla: Sanolla produces AI-enabled smart stethoscopes and respiratory diagnostic devices, addressing similar continuous lung sound and cough detection use cases as Strados's RESP® Biosensor.
- Biofourmis: Biofourmis provides wearable-based remote patient monitoring and digital endpoint platforms for decentralized clinical trials, overlapping with Strados's at-home continuous respiratory monitoring value proposition.
- Medable: Medable is a leading decentralized clinical trial platform with remote monitoring and eCOA capabilities, comparable to Strados's DCT integration via Delve Health and its acquired eCOA module.
Direct peers
- Clario: Clario is the largest eClinical endpoint technology provider and a direct respiratory endpoint competitor; it is also Strados's distribution partner for RESP® Biosensor to pharma and biotech sponsors, making it the closest functional comparison.
- Vitalograph: Vitalograph manufactures respiratory diagnostic and monitoring devices including spirometers used in clinical trials and primary care, directly overlapping with Strados's Air Next Spirometer and respiratory endpoint suite.
- ActiGraph: ActiGraph develops wearable biosensors and digital health technology used as clinical trial endpoints (activity, sleep, respiratory proxies), competing for the same wearable-endpoint budget Strados targets.
- Hexoskin (Carré Technologies): Hexoskin makes smart shirts with embedded respiratory and cardiac sensors used in clinical research and remote patient monitoring, offering an alternative wearable form factor for continuous respiratory endpoints.
Broad incumbents
- Evidera (PPD, part of Thermo Fisher): Evidera provides clinical research, real-world evidence and digital endpoint services to pharma across multiple therapeutic areas including respiratory, serving as a broader incumbent adjacent to Strados's specialized endpoint offering.
- Philips Respironics: Philips Respironics is a large established respiratory care and sleep diagnostics manufacturer whose clinical-grade respiratory measurement portfolio overlaps with the broader respiratory monitoring market Strados serves.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Strados Labs social profiles
Digital presenceStrados Labs compliance and trust
Trust signalCompliance7 records
Strados Labs financial estimates
Financial estimateRevenue estimate
Valuation estimate
Strados Labs leadership team
Management profileNumber of profiles
Profiles8 records
Strados Labs subsidiaries and ownership
Company hierarchySubsidiaries1 record
Strados Labs funding detail
Funding detailFunding overview
Funding rounds10 records
Investors10 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Strados Labs M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Strados Labs
What does Strados Labs do?
Strados Labs provides an integrated respiratory endpoint suite for clinical trials, combining FDA 510(k) cleared wearable biosensors (RESP Biosensor, RESP Watch), spirometry (Air Next), FeNO (NObreath), and an eCOA platform with proprietary AI-driven cough and lung sound analysis. The company delivers device provisioning, global logistics, site training, expert human overread, and regulatory-grade data reporting for Phase I-IV respiratory clinical trials conducted by pharmaceutical sponsors and CROs.
Is Strados Labs a public or private company?
Strados Labs is a private company. It is classified as venture growth investor backed and is currently operating.
When was Strados Labs founded?
Strados Labs was founded in 2018. It employs 11 to 50 people.
Where is Strados Labs based?
Strados Labs is headquartered in Philadelphia, United States, in the North America region.
How does Strados Labs make money?
Three revenue lines are on record. Device Sales and Rental is the primary driver. The others are clinical Trial Services and software and Data Services.
Who are Strados Labs's main competitors?
Emerging players on record are Verily Life Sciences, Sanolla, Biofourmis and Medable. Direct peers are Clario, Vitalograph, ActiGraph and Hexoskin (Carré Technologies). Broad incumbents are Evidera (PPD, part of Thermo Fisher) and Philips Respironics.
Does Strados Labs have an API?
No public API is recorded for Strados Labs.
What industry is Strados Labs in?
Strados Labs's product category is Digital Respiratory Endpoints for Clinical Trials. Its primary akta.pro industry code is HLAGACAF, Investigator & Site Training / GCP Support. Its NAICS code is 334510 and its SIC code is 3826.