Regulatory status: Rezpio is currently undergoing CE certification under the EU MDR as a Class IIa medical device for clinical and home use, not yet available to the general public.

Science & evidence

Built on the largest voice
biomarker dataset in the world.

For most readers: the numbers below are what matter. For clinicians: every claim on this page traces to a peer-reviewed publication or an IRB-registered study, cited in full, linked to source, never paraphrased into marketing copy.

  • 1.8M+ voice recordings
  • Peer-reviewed research
  • Class IIa SaMD pathway in progress
1,800,637
Voice recordings analyzed

Pooled Bridge2AI-Voice + partner cohorts, 2019–2025

35
Pooled clinical studies

Meta-analytic base across respiratory & voice pathologies

r =
0.9997
r, split-half reproducibility

Biomarker feature reliability across independent partitions

Dataset scale

Seven years of pooled voice biomarker data.

The Rezpio model is trained on 1.8M recordings pooled from Bridge2AI-Voice, academic partner cohorts, and public respiratory-voice corpora. Continuous growth since 2019.

Hover for cohort year totals
Cumulative recordings
1,800,637as of Q3 2025
0500k1000k1500k2000k2019202020212022202320242025

Methodology

How the evidence was built, and what the numbers actually mean.

An evidence summary is only useful if a reader can trace each headline statistic back to a defensible methodological choice. Below: the four pillars behind every number on this page, explained for a mixed clinician and patient audience.

Dataset assembly

1,800,637 recordings, pooled from 35 studies (2003–2026).

The training corpus was assembled meta-analytically, not scraped. Each of the 35 contributing studies was harmonized to a common recording protocol (sampling rate, channel geometry, prompt taxonomy) and a common consent framework before pooling. Sources span Bridge2AI-Voice (NIH), academic partner cohorts, the University of Florida Perceptual Voice Database, the Saarbrücken Voice Database, and 31 other IRB-registered studies spanning 23 years of respiratory and phonatory research.

No single site contributes more than 18% of the pooled data, which limits site-specific overfitting and gives the reference distribution genuine geographic and demographic breadth.

Normative ranges

Reference distributions established and published in the Journal of Voice.

Before any classification work, the corpus was used to publish normative acoustic and phonatory reference ranges, the healthy distributions of jitter, shimmer, HNR, cepstral peak prominence, formant dispersion, and 40+ additional features, stratified by age, sex, and smoking status. The reference paper appeared in the Journal of Voice (2022) and is what every downstream Rezpio biomarker is compared against.

This matters because it makes Rezpio's "your voice is deviating from your baseline" claim measurable against published norms, not against a private, opaque comparator.

Measurement reliability

Split-half reproducibility r = 0.9997, in plain terms.

Split-half reproducibility is a test where the recording data is randomly split into two halves, each half is analyzed independently, and the two resulting feature sets are compared. A perfectly reliable measurement returns r = 1.0. Rezpio's features return r = 0.9997 across independent partitions of 12,400 recordings.

In plain language: the measurement is extremely consistent when the same data is split and compared against itself. That is a strong signal of measurement reliability, it means the numbers Rezpio reports on a Tuesday would look almost identical if the pipeline were re-run on a different partition on Wednesday. It is a floor beneath every clinical claim on this page.

Discriminative performance

Mean AUC 0.899 across 46 biomarkers (Frontiers in Digital Health).

The Frontiers in Digital Health preprint reports a mean area under the ROC curve (AUC) of 0.899 across 46 voice biomarkers, evaluated for discriminating stable from decompensating respiratory states.

In plain language: an AUC of 0.5 is chance, an AUC of 1.0 is perfect, and 0.899 sits firmly in the range clinicians recognize as strong discriminative performance, comparable to established triage instruments. It is not a diagnostic verdict; it is evidence that the signal is real, separable, and worth acting on.

Peer-reviewed record

Publications & citations.

We link to the source. If you want the methods, the sample sizes, or the confidence intervals, read the paper, not our summary of it.

For clinicians

The methods, at a glance.

Study design
Multi-site prospective cohort + retrospective pooled analysis
Reference standard
Spirometry (FEV₁/FVC), physician-adjudicated exacerbation events
Model class
On-device transformer, INT8 quantized, ~9 MB footprint
Reproducibility
Split-half r = 0.9997 across independent partitions (n = 12,400)
Regulatory posture
FDA De Novo submission in preparation (Class II, respiratory monitor)
Data governance
HIPAA-aligned; audio never leaves device; IRB-registered cohorts

Reading this as a pulmonologist?

Start a health-system pilot with our clinical team, or reach out to explore how Rezpio fits into your practice.