EchoSolv enters Mayo’s test zone as it chases FDA approval

• EchoSolv enters Mayo’s gauntlet for FDA nod
• Echo’s AI flags heart failure before it hits the fan
• Other ASX stocks that have trialled with Mayo

On July 1, Echo IQ released an announcement that made cardiologists sit a little straighter.

The Sydney-based outfit said its heart-failure software, EchoSolv HF, has officially entered Mayo Clinic Platform’s “Validate” program.

If you haven’t bumped into that term before, Validate is Mayo’s obstacle course.

An independent crew takes your algorithm, runs it against mountains of data, and publishes a verdict on accuracy, bias and clinical usefulness.

Pass the test and you’ve earned real bragging rights, plus the clean dossier the FDA likes to see attached to a 510(k) submission.

“We’re excited to commence the study, which we believe will provide additional validation of the technology,” said EchoIQ’s CEO, Dustin Haines.

“This marks the next step in our stated strategy to achieve FDA clearance for EchoSolv HF in the second half of this calendar year.”

So why the urgency?

Because heart failure is America’s priciest revolving door – US$60 billion a year in hospital readmissions and climbing.

Echo IQ’s plan is to slip EchoSolv into the echo review process, right when the report first lands, so at-risk patients can be flagged early and long before they boomerang back to emergency.

Unlike image-heavy rivals, EchoSolv reads the echo report itself – 140-plus measurements captured during a standard scan – and spits out a risk score in under a minute.

An echo by the way, is short for echocardiogram – a quick, painless ultrasound scan that turns sound waves into moving pictures and measurements of how your heart’s pumping.

With EchoSolv, US hospitals won’t need new probes or hardware, just a browser tab and the existing reimbursement code 93799.

Evolution Capital, which has slapped a 74-cent fair value on the stock (versus EIQ’s current stock price of 24 cents ), points to an almost pristine AUC of 0.986 for EchoSolv-AS (the aortic stenosis version) in a Harvard study of more than 31,000 patients.

AUC is ‘area under curve’, where 1 means perfect accuracy.

That performance, plus an exclusive pipeline of 60 US hospitals on top of 41 early partners, gives Echo IQ a running start if the FDA thumbs-up lands on schedule, Evolution said.

AI that sees heart failure coming

EchoSolv HF takes the 140+ measurements already found in a standard echo report, runs them through a mixture-density neural network, and spits out a heart failure risk score in seconds.

The AI technology was trained on more than a million echo studies from the National Echo Database of Australia.

These records are linked to real patient outcomes, so the model learned to spot the early signs of heart failure based on how those patients actually fared.

In two 2024 proof-of-concept trials, the AI tool picked up 86% of heart-failure cases compared to 46% with standard clinical review. When doctors added the AI’s score to their own read, accuracy jumped to 97%.

EchoSolv HF shares the same tech DNA as the EchoSolv-AS, which looks specifically for severe aortic stenosis – the valve-narrowing disease that can march quietly toward heart failure if surgeons don’t intervene.

EchoSolv-AS has already cleared the FDA, thanks to that near-perfect performance (AUC 0.986) in a Harvard Beth Israel validation of 31,000-plus patients.

Who else Mayo has worked with

Meanwhile, the Mayo badge matters because Mayo’s data library is deep and its scepticism is legendary.

It also has form for turbo-charging Aussie med-techs.

Wind the clock back to 2016: ProMedicus (ASX:PME) inked an $18 million radiology-software deal with Mayo and set off on a nine-year share-price moonwalk.

HeraMED (ASX:HMD) previously ran a fetal‑heartbeat study at Mayo’s Minnesota campus, Noxopharm added Mayo sites to its CEP‑2 sarcoma trial in mid‑2022.

Optiscan (ASX:OIL) signed a Mayo co‑development deal on robotic breast‑cancer imaging last year.

More recently, EMvision Medical Devices (ASX:EMV)’s bedside stroke scanner caught Mayo clinicians’ eyes; the Florida campus is now part of its pivotal trial, and a De Novo submission is in the works.

And now, EchoIQ said if all the planets line up, the FDA decision could arrive before Christmas trees go up.

Of course, Stockhead is not suggesting these names will match the ProMedicus playbook, but Mayo’s interest tends to be more than just polite curiosity.

At Stockhead we tell it like it is. While EMVision is a Stockhead advertiser, it did not sponsor this article.

This story does not constitute financial product advice. You should consider obtaining independent advice before making any financial decision.