Health AI's Path to Payment: Setbacks and Progress in the US Market
The journey for new medical technology in the United States is rarely a straight line, especially when it involves artificial intelligence. Recent events highlight the regulatory hurdles and market wins shaping the future of AI in healthcare.
Echo IQ Faces Reimbursement Setback, Pivots to Plan B
Heart disease detection company Echo IQ (ASX:EIQ) experienced a "frustrating" rejection for a Category III Current Procedural Technology (CPT) code in the US. The code was for its AI-powered aortic stenosis tool, Echosolv AS, which analyzes echocardiograms to produce a rapid risk assessment.
CPT codes are essential. They create a standard language for medical services, enabling efficient payment from insurers and Medicare. Without a specific code, securing reimbursement becomes a significant challenge.
The company has a multi-pronged response. It is eyeing new AI-specific codes proposed for next year, which are designed for services that augment a physician's work. Echo IQ is also considering an appeal with the American Medical Association (AMA) and will use an existing miscellaneous code in the interim.
CEO Dustin Haines called the decision a bump in the road, expressing confidence that engagement with regulators will pay off as new AI frameworks develop. The company continues to advance its broader heart failure tool, Echosolv HF, with a validation study at the Mayo Clinic nearing completion.
Artrya Secures Major US Hospital for Plaque Trial
In contrast, Artrya (ASX:AYA) has enlisted a large specialist heart hospital for its Sapphire clinical trial. The Huntsville Hospital Heart Centre in Alabama will help test Salix, Artrya's AI platform for assessing coronary artery plaque from CT scans.
Huntsville is a high-volume center, handling over a million outpatient procedures annually. This partnership adds significant weight to the trial, which is scheduled to begin in early 2026. High-risk plaque is a critical indicator of heart disease that current methods often miss.
Artrya is well-funded after a recent $80 million capital raise. The company already has FDA approval for two modules of its Salix platform and expects approval for a third, Salix Coronary Flow, early next year.
Dorsavi Gains Traction in US Physical Therapy
Movement analysis specialist Dorsavi (ASX:DVL) is seeing strong adoption in the American physical therapy (PT) market. A recent training event for its Vimove product resulted in a 90% conversion rate, with 27 of 30 attending clinics signing on.
This is a sharp increase from the company's typical 4-5 new subscriptions per month. Vimove provides objective, report-style motion analysis for surgeons and patients. With a US market of over 66,000 PT clinics, Dorsavi sees an inflection point for significant growth and is planning more training events across the country.
Other Health Tech Updates
- ECS Botanics (ASX:ECS): The medical cannabis producer achieved positive cash flow in the September quarter. It is countering a market flooded with lower-quality imports by emphasizing its organic certification and Good Manufacturing Practice standards while expanding into Europe.
- TrivarX (ASX:TRI): This mental health company is in a trading halt pending news on a clinical trial, a material acquisition, and a potential capital raise. The trial is evaluating an ECG algorithm for detecting depression in veterans.
- PainChek (ASX:PCK): Shares are paused as the company awaits an FDA decision on its digital pain management application for the US market.
