Signal quality first. Marketing name last.

The open question was never whether the body produces measurable mechanical signals. It was which features are repeatable, meaningful and useful for a defined purpose. That gets answered in order: signal quality, then repeatability, then sensitivity and specificity to context, then agreement with an established ground-truth reference, then performance in a defined population and use case.

This page states where each claim currently sits in that order, and what it would take to move.

Registered human trials

The following studies are registered on ClinicalTrials.gov. The timescale column ties each one back to the fast, slow and slowest framing: this is a programme, not a scatter.

StudyIdentifierTimescale class
imPulse® UNA Infrasound-to-Ultrasound E-Stethoscope NCT04941209 Platform
imPulse® UNA Full-Spectrum, Over-Clothing E-Stethoscope NCT04556149 Platform
Vibroacoustic Study of Lung Development in Newborn Infants NCT05827250 Slowest — developmental
SARS-CoV-2/COVID-19 Study of Next-Generation Non-Invasive Passive Detection Technologies NCT05765396 Fast — acute infectious
Rapid Research in Diagnostics Development for TB Network NCT04923958 Fast — acute infectious
imPulse™ Tor System Self-Directed Cuffless Blood Pressure Monitoring NCT05386654 Slow — cardiovascular

Scale of the human data foundation

Across these programs the human-data foundation exceeds 20,000 participants. Acquisition is fully passive throughout, and no device-related adverse events have been reported.

That data has been collected across three timescales — acute infectious, non-communicable cardiopulmonary and gut, and maternal and fetal — at leading clinical research centers.

20,000+participants, fully passive acquisition
6registered human trials on ClinicalTrials.gov
2,500510(k)-exempt imPulse® UNA units, manufacturing pilot completed

Not one study. A swarm.

2,500 510(k)-exempt imPulse® UNA units have completed manufacturing and are deploying into global registered heart, lung and gut programs spanning all three timescales — infectious, non-communicable and chronic. The aim is a reference atlas: what coherence decoupling looks like by disease, age, sex and condition, and what departure precedes deterioration.

The genome needed a map before it became useful. So does the vibrome.

Partners

Vibrome® data collection and validation has been conducted in collaboration with the Gates Foundation, the Clinton Health Access Initiative, the U.S. Department of Defense including the USAF 59th Medical Wing, the Uniformed Services University of the Health Sciences, Johns Hopkins University, the University of California San Francisco, and Georgetown University Medical Center. The inaugural COVID-19 clinical study at Johns Hopkins was sponsored by Schmidt Futures.

Regulatory status

The imPulse® UNA transducer platform is registered and listed with the FDA under product code DQC, listing ID 922165. That listed platform is the Point-of-Need sensing core. Point-of-Habitat® is a zero-effort longevity configuration of the same technology, extending the core in four respects: noise floor and signal conditioning, multimodal sensor hardware, edge inference, and cross-signal validation. Listing is not clearance or approval, and no Vibrome®-derived index is currently cleared or approved as a diagnostic.

Current positioning is early detection, triage and wellness monitoring. Disease decision-support requires its own regulatory pathway. US policy distinguishes general wellness functionality from software intended to diagnose, treat, mitigate or prevent disease, and we position accordingly.

Claim and evidence table

Each row states where the claim sits and where it comes from, so a reader can check it rather than take it.

The body generates mechanical signals

Established science
Physics of fluid–structure interaction; general literature

Cardiac mechanical motion can be sensed externally

Established modality
Seismocardiography and ballistocardiography literature

Signal morphology changes with respiration and exertion

Supported experimentally
Cardiomechanical sensing literature

The signal is detectable through clothing

Supported
NCT04556149 — full-spectrum over-clothing e-stethoscope

The signal separates disease states

Supported
NCT04923958 (TB), NCT05765396 (COVID-19)

Acquisition scales outside a laboratory

Demonstrated
2,500-device manufacturing pilot; field deployment

Recovery dynamics carry information about resilience

Active research
Vibrome® mapping studies, in progress

42ndMovement™ quantifies healthspan

In active validation — not established
No validated longevity endpoint exists for any technology

The limits, stated plainly.

  • Longevity is not a validated surrogate endpoint — not for Vibrome® and not for any other technology. Earning that validation is the work ahead, not a claim behind us.
  • Evidence for disease-state discrimination is not evidence for longevity measurement. We report them separately and ask that they be read separately.
  • No Vibrome®-derived index is currently cleared or approved as a diagnostic.

These constraints shape every study we design, and we would rather state them than discover them with a partner mid-protocol.