Platform / Spirometry | Strados Platform

Strados Spirometry

Meets ATS/ERS 2005 & 2019 Standards

Strados supports both investigator-site primary endpoints and continuous at-home monitoring — same device, same data quality, one integrated workflow.

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ATS/ERS 2005 & 2019 Compliant

All spirometry meets the latest international acceptability and repeatability standards

Expert Overread

Centralized quality review by trained spirometry specialists for every test

In-Clinic & At-Home

Same device supports primary endpoints at site and continuous at-home monitoring

Remote Telehealth Coaching

Real-time video coaching and app-guided instructions for at-home maneuvers

Deployment Modes

In-Clinic & At-Home

The Strados Air Next supports both investigator-site primary endpoints and continuous at-home monitoring — same device, same data quality, one integrated workflow.

Primary Endpoints

In-Clinic Spirometry

Investigator-site spirometry that supports primary and key secondary endpoints in pivotal trials. Technician training, calibration and quality control, and centralized expert overread ensure data meets the highest regulatory standards.

Supports FEV₁, FVC, FEV₁/FVC as primary endpoints
Technician training & certification
Calibration & quality control at every site
Expert overread & acceptability grading
Regulatory validation documentation

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Between-Visit Monitoring

At-Home Spirometry

Extend pulmonary function testing into daily life between clinic visits. The Strados remote telehealth platform provides real-time video coaching and app-guided instructions so patients perform maneuvers correctly — from home.

Remote telehealth platform with real-time video coaching
App-guided maneuver instructions for patients
Automated quality and acceptability feedback
Site & patient support throughout the trial
Logistics & device provisioning managed end-to-end

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Measures

Spirometry Measures

Comprehensive pulmonary function parameters meeting ATS/ERS 2005 & 2019 acceptability and repeatability standards.

Available Parameters Include:

FEV₁Key endpoint
Forced Expiratory Volume in 1 second
FVCKey endpoint
Forced Vital Capacity
FEV₁/FVCKey endpoint
Tiffeneau-Pinelli index
PEFKey endpoint
Peak Expiratory Flow
FEF25-75%
Forced Expiratory Flow at 25–75% of FVC

All measures meet ATS/ERS 2005 & 2019 acceptability and repeatability criteria.

Standards Compliance

ATS/ERS 2005

Acceptability & repeatability criteria for FVC maneuver

ATS/ERS 2019

Updated quality grading and back-extrapolation standards

21 CFR Part 11

Electronic records & audit trail compliance

HIPAA

Patient data privacy and security

Full-Service Spirometry

Everything Included

Strados delivers a complete spirometry service — from hardware to human expertise.

Handheld Spirometers & Companion App

The Strados Air Next (NuvoAir Air Next) with companion smartphone app for guided maneuver instructions and real-time patient feedback.

Expert Overread

Centralized review by trained spirometry specialists. Every test is assessed for acceptability, repeatability, and quality grading.

Calibration & Quality Control

End-to-end calibration management and QC protocols at every investigator site to maintain data integrity throughout the trial.

Technician Training

Comprehensive training programs for site staff, covering ATS/ERS maneuver technique, device operation, and troubleshooting.

Regulatory Validation

Full validation documentation, IQ/OQ/PQ, and audit-trail support to meet regulatory submission requirements globally.

Remote Telehealth Coaching Platform

Real-time video coaching for at-home spirometry sessions, ensuring patients perform maneuvers correctly without clinic visits.

Site & Patient Support

Dedicated support throughout the trial lifecycle — from site activation to patient onboarding and ongoing helpdesk access.

Logistics & Device Provisioning

End-to-end device management including shipping, inventory tracking, returns, and replacements across all global trial sites.

Proven Clinical Trial Experience

Strados spirometry credentials span 55+ clinical trials, 150+ global sites, and 45+ peer-reviewed publications. Strados spirometry capabilities are powered by our 2025 acquisition of NuvoAir's clinical trial business.

55+

Clinical Trials

150+

Global Sites

30+

Countries

45+

Publications

Location-Agnostic Spirometry

The Air Next eliminates the need for fixed workstations — the same FDA-cleared device supports ATS/ERS-validated spirometry at investigator sites, in patients' homes, and anywhere in between.

Integrated Telemedicine

Virtual patient and visit management with fully integrated video and messaging services, replicating the in-person coaching experience for at-home maneuvers.

Real-Time Data Transfer

Spirometry data connects wirelessly and is securely transferred to the cloud in real-time, enabling immediate quality review, risk-based monitoring, and rapid decision-making.

Multi-Modal Endpoint Integration

Beyond spirometry, the platform also supports FeNO, cough monitoring, ePRO/eCOA, pMDI inhaler sensors, and SpO₂ — all within a single unified clinical trial environment.

Strados Air Next: FDA-cleared · CE marked · ISO 13485 certified · Meets ATS/ERS/ISO waveform testing requirements

Strados Intelligence Advantage

High-quality spirometry data starts with high-quality review

Every spirometry session is first analyzed using AI-powered quality assessment from ArtiQ, which evaluates maneuvers against ATS/ERS quality criteria and identifies potential quality issues. Certified pulmonary function experts then perform centralized overread to confirm quality, review complex cases, and ensure reliable, trial-ready data.

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Endpoint Suite