Strados was founded by a patient and clinician who believed respiratory disease could be measured better. Everything we build, every study we design, and every data point we deliver reflects that origin.
Strados was founded with a single conviction: that respiratory disease could be measured better. That conviction came from our founders — Nick Delmonico (CEO, former asthma patient) and Dr. Yu Kan Au (clinician co-founder). Episodic clinic visits, subjective assessments, and fragmented vendor relationships were producing data that failed to reflect how patients actually experienced disease in their daily lives. We set out to change that.
Our first breakthrough was building the world's first FDA-cleared device to continuously capture lung sounds — a wearable biosensor that could monitor cough, wheeze, and respiratory patterns ambulatorily, outside the clinic, in real patients' real lives. That achievement wasn't a milestone we celebrated and moved past. It was a proof of how we think — always ahead of where the science is going, not catching up to where it has been.
In 2026 we acquired NuvoAir's clinical trial business — bringing validated remote spirometry, FeNO measurement, and eCOA together with our gold-standard cough monitoring and lung sound analysis. The result is a single specialist partner capable of delivering the full spectrum of respiratory endpoints for Phase I–III clinical trials, anywhere in the world.
2018
Founded
Strados Labs established by respiratory medicine and clinical research specialists
2020
First FDA clearance
World's first FDA 510(k) cleared device for continuous ambulatory lung sound monitoring
2021
CE Mark
European regulatory clearance achieved
2024
Global expansion
Deployed across 34 countries and 234+ investigator sites
2026
NuvoAir acquisition
Acquisition of NuvoAir's clinical trial business adds spirometry, FeNO, and eCOA to the Strados Endpoint Suite
We believe the most meaningful respiratory data comes from patients' real lives. The moments that matter most for understanding treatment response happen at home, at night, during daily activity. That belief drives every device we design, every endpoint we select, and every study we help sponsors build.
We are equally committed to the patients who wear our devices and the scientists who depend on our data. Low-burden wearables and home-based assessments are not a compromise — they are a deliberate design choice that produces better science and better data because patients comply, persist, and live their normal lives while wearing them.
Measuring what matters to patients, in the way they actually experience disease, is not just good ethics. It is better science.
Every Strados device, algorithm, and process is built to the standard that pivotal trials demand.
FDA 510(k) cleared
RESP Biosensor
CE Mark
RESP Biosensor and Strados Air Next
ISO 13485 certified
Quality management system
GCP compliant
All study delivery processes
ATS/ERS 2019
Spirometry quality standard
65+ publications
Peer-reviewed evidence base
55+ clinical trials
Phase I–III delivered
Our approach to evidence quality goes beyond device clearance. Retained audio on every cough event enables human expert review and full regulatory audit — a standard that algorithm-only solutions cannot meet. Every spirometry maneuver is centrally overread by respiratory specialists. Every data point is traceable, defensible, and built for submission.
This is what separates Strados from device companies, algorithm-only monitoring solutions, and generic eClinical platforms. Intelligence is not a feature. It is the standard we hold every data point to.
The acquisition of NuvoAir's clinical trial business created something that did not previously exist in the market — a single respiratory endpoint intelligence company capable of delivering cough monitoring, spirometry, FeNO, lung sound analysis, and eCOA from one partner, across one contract, with one data stream.
For sponsors and CROs, this means no more fragmented vendor relationships, no more mismatched data standards, and no more coordinating between multiple providers for endpoints that belong in the same program. Strados manages the complete respiratory endpoint layer — devices, training, quality control, expert overread, logistics, and regulatory documentation — so your team can focus on the science.
Deployed across 34 countries and 234+ investigator sites, we have the global infrastructure to support complex multi-regional trials from Phase I through pivotal.
Tell us about your program and we'll help you build the right endpoint strategy.
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