Strados Labs Inc.

Strados Labs is a respiratory-focused clinical trial solutions company delivering regulatory-grade endpoint data for pharmaceutical and biotech sponsors through Phase I–IV trials across 34 countries. The company specializes in continuous, ambulatory respiratory monitoring combined with AI-driven analysis and expert human review to capture disease burden between clinic visits. Product offerings include the Air Next Spirometer (FDA-cleared spirometry with FEV₁, FVC, FEV₁/FVC measurement), RESP® Biosensor (FDA 510(k)-cleared wearable capturing high-fidelity cough, lung sounds, vitals, and activity), RESP® Watch (clinical-trial-ready cough and activity monitoring), NObreath® FeNO (point-of-care fractional exhaled nitric oxide for airway inflammation assessment), and eCOA software suite (ePRO, eClinRO, eObsRO for electronic patient-reported and clinician-reported outcomes). Strados recently acquired NuvoAir's clinical trial business to expand its integrated endpoint platform. All devices are FDA 510(k) cleared, CE-marked, and ISO 13485 certified. The company has accumulated 87,000+ hours of respiratory data across 55+ clinical studies and published 70+ peer-reviewed papers in respiratory research journals including ERJ, CHEST, and npj Digital Medicine. Services include study design consultation, site support, device logistics, and GCP-compliant data delivery. The company serves pharma sponsors and contract research organizations seeking single-vendor respiratory endpoint solutions with retained audio, AI detection paired with expert review, and full audit trails for regulatory submission.