ASX-listed Echo IQ has obtained regulatory approval in the United States for its AI-driven solution that supports structural heart disease diagnosis.

WHAT IT'S ABOUT

Two years since coming to the US, the company has now received 510(k) clearance from the Food and Drug Administration for EchoSolv AS, which is specifically indicated to support the diagnosis of severe aortic stenosis (a form of heart valve disease). It submitted an FDA application in May.

Its software automates the identification of aortic stenosis based on clinical practice guidelines and through AI-driven phenotype analysis. Several studies conducted in Australia and the United States have confirmed the AI software's effectiveness and accuracy in detecting individuals at high risk of aortic stenosis – which goes up to 97%, the company claims.

Echo IQ's recent A$7.1 million ($4.7 million) raise backs this major milestone in the company, which is currently developing more heart disease diagnosis AI solutions and pursuing global expansion.  

Following the FDA clearance, Echo IQ will now focus on selling its software product in the US, according to executive chair Andrew Grover; the company has made initial partnership talks with a "number of hospital groups" and explored potential licensing deals with device manufacturers and pharmaceutical firms.

"The company will also scale work alongside its US consultancy to obtain reimbursement codes for users of EchoSolv AS under insurance. This will create financial incentives for more widespread use of [the software] in US hospital settings on a fee-per-use basis," Echo IQ added.

Meanwhile, the company is on the lookout for a US-based CEO. 

MARKET SNAPSHOT

Last month, fellow Australian company See-Mode Technologies from Victoria also received what could be the first 510(k) clearance for an  AI-powered solution to identify and diagnose thyroid issues on ultrasound scans.

Salix is another heart disease AI solution that has gained traction in Australia in recent years. Developed by a collaboration of medical institutes, the software reportedly can detect and assess atherosclerotic plaque in the arteries as seen in a patient's CT scan and provide a quick detailed report, including vulnerable plaque, stenosis, calcium score and total plaque burden.