EchoIQ FDA rejection read-through

Sector Spotlight · Health Care

Sector Spotlight · 7 September 2026

Health Care

Sector Spotlight · Health Care

EchoIQ FDA rejection read-through

The AFR reports that EchoIQ (ASX:EIQ) has failed to secure FDA approval for EchoSolv Heart Failure. We analyse the read-through for other MedTech algorithms based on FDA approval status. 4DMedical (ASX:4DX) already has FDA approval for CT:VQ, XV LVAS and CT LVAS and in our view is not at risk.

A more cautious approach? Recent news flow in the US healthcare sector has seen the American Board of Radiology taking cautious approach to AI, and a study showing most FDA-cleared AI medical devices not tested on patient outcomes and FDA seeking feedback on how to regulate generative AI in medicine. As highlighted in our weekly comments, this could be a sign that after experiencing a period of strong FDA approvals, a more cautious approach may be adopted going forward.
4DX least at risk: Of the ASX listed medtech companies with AI/algorithms seeking FDA approval, we see 4DX as being the least at risk, with its XV LVAS, CT LVAS and most importantly flagship CT:VQ algorithm having already been granted FDA approval Fig 1.
PME read-thru: PME’s FY26 valuation assumed a 60% probability of EIQ HF clearance (pg69). Its sensitivity analysis said reducing that probability to zero, holding other inputs constant, would reduce the asset value by approximately A$0.9m.

Fig 1: ASX medtech companies FDA approval status

Company	Ticker	Diagnostic algorithms / products	FDA status
4DMedical	ASX:4DX	XV LVAS / CT LVAS: regional lung ventilation analysis.	Cleared
4DMedical	ASX:4DX	CT:VQ: lung ventilation and perfusion mapping from non-contrast CT scans.	Cleared
Artrya	ASX:AYA	Salix Coronary Anatomy: coronary anatomy and disease assessment from coronary CT angiography.	Cleared
		Salix Coronary Plaque: plaque quantification and characterisation.	Cleared
		Salix Coronary Flow: assessment of the functional significance of coronary narrowing.	Not Cleared
EchoIQ	ASX:EIQ	EchoSolv AS: identifies severe aortic stenosis using echocardiographic data.	Cleared
EchoIQ	ASX:EIQ	EchoSolv HF: identifies heart failure using echocardiographic data.	Not Cleared
BlinkLab	ASX:BB1	Dx1: smartphone-based behavioural biomarkers to assist autism diagnosis.	Not Cleared
BlinkLab	ASX:BB1	Dx2: related algorithm under development to assist ADHD diagnosis.	Not Cleared
CurveBeam AI	ASX:CVB	BMD software: automated bone mineral density assessment from CT, initially for multidetector CT, with a subsequent extension planned for HiRise scanners.	Not Cleared
EMVision	ASX:EMV	emu: portable brain scanner incorporating algorithms for stroke-type detection.	Not Cleared
EMVision	ASX:EMV	First Responder: portable pre-hospital brain-scanning programme.	Not Cleared

Source: Company data, Homodeus research

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Price and valuation as at 7 September 2026 (*not covered)

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