--- id: "76216332-cb87-4a92-8750-8baf14b4fcde" title: "EchoIQ FDA rejection read-through" report_type: "sector-spotlight" published_date: "2026-09-07" source: "Homodeus Research" source_url: "https://homodeus.one" report_url: "https://homodeus.one/research/report/health-care-echoiq-fda-rejection-read-through-sector-spotlight" lead_analyst: "Wei Sim" lead_analyst_email: "wei.sim@homodeus.one" access: "full" requires_payment: false issuer_paid: true html_access: "free-registration" html_registration_required: true sector: "Health Care" gics_sector: "Health Care" gics_industry_group: "Equipment & Services" currency: "AUD" publication_date: "2026-09-07" price_date: "2026-09-07" commissioned_by: "Health Care" markdown_url: "https://homodeus.one/api/reports/health-care-echoiq-fda-rejection-read-through-sector-spotlight.md" bot_friendly: true keywords: "Health Care, Medtech Algorithms, regulatory approval" modified_date: "2026-10-10T12:46:52.561Z" --- # EchoIQ FDA rejection read-through **Industry Group:** Equipment & Services The [AFR reports](https://www.afr.com/street-talk/medical-ai-firm-stumbles-over-tga-hurdle-fails-to-get-approval-20260907-p60v4m) 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. ## Key Highlights - 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 ?. - 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$0.9m. - | Company | Ticker | Diagnostic algorithms / products | FDA status | - | --- | --- | --- | --- | - | 4DMedical | ASX:4DX | XV LVAS / CT LVAS: regional lung ventilation analysis. | Cleared | - | CT:VQ: lung ventilation and perfusion mapping from non-contrast CT scans. | Cleared | - | Artrya | ASX:AYA | Salix Coronary Anatomy: coronary anatomy and disease assessment from coronary CT angiography. | Cleared | - | Salix Coronary Plaque: plaque quantification and characterisation. | Cleared | - | Salix Coronary Flow: assessment of the functional significance of coronary narrowing. | Not Cleared | - | EchoIQ | ASX:EIQ | EchoSolv AS: identifies severe aortic stenosis using echocardiographic data. | Cleared | - | EchoSolv HF: identifies heart failure using echocardiographic data. | Not Cleared | - | BlinkLab | ASX:BB1 | Dx1: smartphone-based behavioural biomarkers to assist autism diagnosis. | Not Cleared | - | Dx2: related algorithm under development to assist ADHD diagnosis. | Not Cleared | - | CurveBeam AI | ASX:CVB | BMD software: automated bone mineral density assessment from CT, initially for multidetector CT, with a subsequent extension planned for HiRise scanners. | Not Cleared | - | EMVision | ASX:EMV | emu: portable brain scanner incorporating algorithms for stroke-type detection. | Not Cleared | - | First Responder: portable pre-hospital brain-scanning programme. | Not Cleared | --- ## Disclosures ### Company disclosures The companies and securities mentioned in this report include: *Health Care () | Price: A$—
4DMedical Limited (ASX:4DX) | Price: A$3.6
*Artrya Limited (ASX:AYA) | Price: A$4.18
*Echo IQ Limited (ASX:EIQ) | Price: A$1.28
*Pro Medicus Limited (ASX:PME) | Price: A$173.95
*BlinkLab Limited (ASX:BB1) | Price: A$0.755
*CurveBeam AI Limited (ASX:CVB) | Price: A$0.02
*EMVision Medical Devices Ltd (ASX:EMV) | Price: A$1.88 *Price and valuation as at 7 September 2026 (*not covered)* ### Other disclosures, disclaimers and certificates **Methodology & Disclosures** Homodeus One Pty Ltd (ABN 83 696 272 116), is a Corporate Authorised Representative (No. 1320577) of Sharewise Compliance and Administration Pty Ltd (AFSL 280420). This research is issued in Australia through Homodeus Research, which is the research division of Homodeus One Pty Ltd. The research and any access to it is general advice only and does not take into account your personal circumstances, needs, or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation, and needs. If our advice relates to the acquisition, or possible acquisition, of a financial product you should read any relevant Product Disclosure Statement or like instrument. 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