Breaking: FDA clears CorVista System with Pulmonary Hypertension Add-On 82% sensitivity · 92% specificity · >99% negative predictive value Series C closes at $65M — total funding nears $100M Heart testing with no radiation, no contrast, no treadmill Two FDA clearances: coronary artery disease & pulmonary hypertension Breaking: FDA clears CorVista System with Pulmonary Hypertension Add-On 82% sensitivity · 92% specificity · >99% negative predictive value Series C closes at $65M — total funding nears $100M Heart testing with no radiation, no contrast, no treadmill Two FDA clearances: coronary artery disease & pulmonary hypertension
Company Dossier · Medical Technology

A heart test that fits on a tabletop and answers in minutes.

CorVista® Health applies machine learning to cardiovascular diagnostics - capturing the heart's signals at the point of care and sending them to the cloud for an answer, no catheter required.

Pictured: the CorVista wordmark, the only logo we know of with a checkmark hiding in the "V" - fitting, for a company whose whole job is delivering a verdict on your heart.

Toronto, Canada Founded 2012 Formerly Analytics 4 Life FDA-cleared ×2 ~$100M raised
The Scene · 2026

A patient sits still. An algorithm reads the heart.

In an exam room - not a cath lab, not a radiology suite - a patient leans back while a small device records the electrical and hemodynamic signals their heart is already broadcasting. No needle. No dye. No treadmill. A few minutes later, a secure web portal returns a verdict: how likely is coronary artery disease, how likely is pulmonary hypertension. The doctor reads it before the patient has finished buttoning a sleeve.

That room is the entire argument for CorVista Health. The company sells the idea that advanced cardiac testing does not have to mean a hospital, a wait, or a procedure with risks of its own. It is a deceptively modest pitch for a stubbornly hard problem.

"Through CorVista, we are seeing how the power of machine learning can revolutionize care pathways, enabling earlier-stage detection."

— Ian Shadforth, VP & General Manager, CorVista Health
The Problem They Saw

The heart hides in plain sight.

Cardiovascular disease is the world's leading cause of death, and yet the path from "something feels wrong" to "here is what's wrong" is often long and expensive. Coronary artery disease can simmer for years. Pulmonary hypertension is notorious for hiding - patients can wait years and see several specialists before anyone names it.

The standard tools are good, but heavy. Stress tests need exercise some patients can't do. CT angiography needs radiation and contrast. The gold standard for pulmonary pressure is right-heart catheterization, an invasive procedure done in a hospital. Each gate narrows the funnel. People who are old, frail, rural, or simply far from a major cardiac center fall out of it.

Translation: the most accurate heart tests are also the ones hardest to get to. That gap, not the technology, is the thing CorVista is actually attacking.

"There has never been a more critical need for point-of-care diagnostic modalities that provide rapid testing for cardiac patients."

— Don Crawford, then-CEO, on the Series C
The Founders' Bet

If the heart already speaks, teach a machine to listen.

The company began life as Analytics 4 Life, founded in 2012 on a wager that sounds simple and is not: the signals a heart produces contain more information than human eyes have ever extracted from them, and machine learning could find the patterns. Train algorithms on real-world data from thousands of patients whose true diagnoses are known, and you might build a model that reads a new patient's signals and estimates their risk.

It is the kind of bet that needs patient capital and an unusual founder. Dino Trevisani fit the bill - a 36-year IBM veteran who had run IBM Canada as President and General Manager before backing a heart-diagnostics startup. The pitch was less "build a better scanner" and more "rebuild the first step of cardiac diagnosis around software." The rebrand to CorVista Health signaled the shift from a research project to a product.

2012
Founded as Analytics 4 Life
$65M
Series C, 2021
~$100M
Total raised
2
FDA clearances

Funding by the numbers. The interesting part isn't the dollar figure - it's that investors paid for years of clinical validation before a single commercial answer was billable.

"This technology has the potential to really improve the time from symptoms to diagnosis."

— Dr. Vallerie V. McLaughlin, University of Michigan
The Product

A capture device on the table. The brains in the cloud.

The CorVista System splits the work in two. At the bedside, a capture device records cardiac and hemodynamic signals - no radiation, no contrast agents, no injections, no fasting, no exercise. Those signals travel to the cloud-based CorVista Analyzer, where proprietary machine-learned algorithms do the math and generate results. The clinician sees them through a secure web portal within minutes.

1

Capture

The patient sits still while the device records the heart's electrical and hemodynamic signals. The whole thing is non-invasive.

2

Analyze

Signals go to the cloud. Machine-learned algorithms, trained on real-world patient data, score the likelihood of disease.

3

Result

A result returns through a secure web portal in minutes, ready for the clinician to act on.

The platform ships as a base system with disease-specific "Add-Ons." The CAD Add-On evaluates the likelihood of significant coronary artery disease. The Pulmonary Hypertension Add-On indicates the likelihood of elevated mean pulmonary artery pressure (mPAP) - and it is, the company says, the first FDA-cleared, machine-learned point-of-care technology for that job. The device itself is developed and manufactured by sister company Analytics for Life and licensed exclusively to CorVista Health.

FDA 510(k) Cleared

CAD Add-On

Assesses the likelihood of significant coronary artery disease as an aid in diagnosis.

FDA Cleared · Breakthrough Device

PH Add-On

Indicates the likelihood of elevated mean pulmonary artery pressure, a marker of pulmonary hypertension.

Cloud

CorVista Analyzer

Where the machine-learned algorithms live and the actual scoring happens - results back in minutes.

Three boxes, one idea: keep the hardware dumb and cheap, keep the intelligence central and improvable. Software you can update beats a scanner you can't.

Milestones

From research wager to regulated device.

2012

Analytics 4 Life is founded on the bet that machine learning can extract diagnosis-grade information from the heart's own signals.

2021 · March

$65M Series C led by Ambix Life Science, with MedVenture Partners and others, brings total funding to nearly $100M.

2022

FDA Breakthrough Device Designation awarded to the CorVista System with PH Add-On for its potential to improve pulmonary hypertension diagnosis.

2023

FDA clears the CAD Add-On, and the company is recognized among top medtech startups.

2024 · April

FDA clears the PH Add-On - a second clearance, and the first machine-learned point-of-care technology for indicating elevated mean pulmonary artery pressure.

The Proof

The numbers behind the PH claim.

Confidence in a screening test lives in its statistics. CorVista's pulmonary hypertension indication was supported by the IDENTIFY PH validation study. Here is what the algorithm posted at identifying patients with elevated mean pulmonary artery pressure.

Sensitivity
82%
Specificity
92%
Negative Predictive Value
>99%

Source: IDENTIFY PH validation study, as reported by CorVista Health. A >99% negative predictive value means a negative result is, statistically, very reassuring.

Read the third bar twice. A near-perfect "no" is exactly what you want from a first-line screen - it lets clinicians rule people out and reserve invasive testing for those who truly need it.

"The Pulmonary Hypertension Add-On underscores our unwavering dedication to advancing novel solutions."

— Jonathan Woodward, CTO, Analytics for Life
The Mission

Shorten the path from symptoms to diagnosis.

The company states its purpose plainly: transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better outcomes. Strip away the press-release polish and the mission is about access - putting a credible first heart test in places that never had one, including underserved populations far from major cardiac centers.

That framing matters because it sets the bar CorVista must clear. A point-of-care test only helps if clinicians trust it and if it actually reaches the people the cath lab never sees. The clinical validation and the two FDA clearances are the company's answer to the first half. The commercial build-out is the unfinished second half.

Who it's for

Clinicians

Cardiologists and physicians who want a fast, non-invasive first read before ordering heavier tests.

Who it's for

Patients

People who can't easily exercise, travel, or tolerate contrast - and those waiting too long for a name for their symptoms.

Who it's for

Health systems

Networks trying to triage cardiac risk earlier and route invasive testing to the patients who truly need it.

Why It Matters Tomorrow

The exam room, revisited.

Go back to that room. The patient is still sitting still, the device still recording, the portal still returning an answer in minutes. What's changed is what that answer is allowed to mean. A decade ago it was a research output. Now it carries two FDA clearances and a validation study behind it - a result a clinician can actually use to decide who needs the catheter and who can go home reassured.

CorVista has not cured heart disease, and it would be silly to pretend a tabletop device replaces a cardiologist. What it has done is move the first, hardest step - getting a credible read on the heart - out of the hospital and into the room where the patient already is. If the company scales that, the long wait from symptom to diagnosis gets shorter for the people who can least afford it. That is the whole bet, and it is still being settled.

No radiation. No contrast. No treadmill. Just signals, the cloud, and a few minutes - and a heart that finally gets a word in.

— The CorVista premise, in one breath

CorVista® Health · Dossier compiled from public sources