Validation study for EchoSolv HF completed at the Mayo Clinic – Study delivers exceptional results
Echo IQ (ASX:EIQ) completed an independent clinical validation of its heart failure decision support software EchoSolv HF with the Mayo Clinic Platform using ~17,000 echocardiogram studies.
The model met its primary endpoint, delivering a sensitivity of 99.5% and a specificity of 91.0%. Completion of this validation is described as the final clinical requirement before a planned FDA 510(k) submission, which Echo IQ expects to lodge in the coming weeks. The company plans to leverage its US footprint to drive uptake if FDA clearance is achieved. A webinar is scheduled for 26 November 2025 at 11:00am AEDT.
Echo IQ (ASX:EIQ) ha completato una convalida clinica indipendente del suo software di supporto alle decisioni per l'insufficienza cardiaca EchoSolv HF, in collaborazione con la Mayo Clinic Platform, utilizzando circa 17.000 studi di ecocardiogramma.
Il modello ha raggiunto l'obiettivo primario, offrendo una sensibilità del 99,5% e una specificità dell'91,0%. Il completamento di questa validazione è descritto come l'ultimo requisito clinico prima di una prevista sottomissione FDA 510(k), che Echo IQ prevede di presentare nelle prossime settimane. L'azienda intende sfruttare la sua presenza negli Stati Uniti per stimolare l'adozione se l'approvazione FDA dovesse essere ottenuta. È programmato un webinar per il 26 novembre 2025 alle ore 11:00 AEDT.
Echo IQ (ASX:EIQ) completó una validación clínica independiente de su software de soporte a la decisión para fallo cardíaco EchoSolv HF con la Mayo Clinic Platform utilizando ~17.000 estudios de ecocardiogramas.
El modelo alcanzó su objetivo primario, logrando una sensibilidad del 99,5% y una especificidad del 91,0%. El completado de esta validación se describe como el último requisito clínico antes de una prevista presentación de FDA 510(k), que Echo IQ espera presentar en las próximas semanas. La empresa planea aprovechar su presencia en EE. UU. para impulsar la adopción si se alcanza la aprobación de la FDA. Se ha programado un seminario web para el 26 de noviembre de 2025 a las 11:00 a. m. AEDT.
Echo IQ (ASX:EIQ)는 Mayo Clinic Platform과 함께 ~17,000건의 심초음파 연구를 사용하여 심부전 의사결정 지원 소프트웨어 EchoSolv HF의 독립 임상 검증을 완료했습니다.
모델은 주된 지표를 충족했고 민감도 99.5%와 특이도 91.0%를 달성했습니다. 이 검증의 완료는 예정된 FDA 510(k) 제출에 앞선 최종 임상 요건으로 설명되며 Echo IQ는 향후 몇 주 안에 제출할 것으로 전망합니다. 이 회사는 FDA 승인 시 미국 내 입지를 활용해 채택을 촉진할 계획입니다. 2025년 11월 26일 11:00am AEDT에 웨비나가 예정되어 있습니다.
Echo IQ (ASX:EIQ) a conclu une validation clinique indépendante de son logiciel d'aide à la décision pour l'insuffisance cardiaque EchoSolv HF avec la Mayo Clinic Platform, en utilisant environ 17 000 études d'échocardiographie.
Le modèle a atteint son objectif principal, affichant une sensibilité de 99,5% et une spécificité de 91,0%. L'achèvement de cette validation est décrit comme l'exigence clinique finale avant une soumission FDA 510(k) prévue, que Echo IQ prévoit de déposer dans les prochaines semaines. L'entreprise prévoit de tirer parti de sa présence américaine pour stimuler l'adoption si l'approbation FDA est obtenue. Un webinaire est prévu le 26 novembre 2025 à 11:00 AEDT.
Echo IQ (ASX:EIQ) hat eine unabhängige klinische Validierung seiner Herzinsuffizienz-Entscheidungsunterstützungssoftware EchoSolv HF in Zusammenarbeit mit der Mayo Clinic Platform abgeschlossen und dabei etwa 17.000 Echokardiogramm-Studien verwendet.
Das Modell hat seinen primären Endpunkt erreicht und eine Sensitivität von 99,5% sowie eine Spezifität von 91,0% erzielt. Der Abschluss dieser Validierung wird als letzte klinische Anforderung vor einer geplanten FDA 510(k)-Einreichung beschrieben, die Echo IQ voraussichtlich in den kommenden Wochen vorlegen wird. Das Unternehmen plant, seine Präsenz in den USA zu nutzen, um die Akzeptanz zu steigern, falls eine FDA-Zulassung erreicht wird. Ein Webinar ist für den 26. November 2025 um 11:00 Uhr AEDT vorgesehen.
Echo IQ (ASX:EIQ) أكملت تحققاً طبياً مستقلاً من برنامج دعم القرار الخاص بفشل القلب EchoSolv HF بالتعاون مع منصة Mayo Clinic Platform باستخدام نحو 17,000 دراسة صدى قلب.
حقق النموذج هدفه الأساسي، محققاً حساسية 99.5% وخصوصية 91.0%. ويُوصف إكمال هذا التحقق كمتطلب سريري نهائي قبل تقديم FDA 510(k) المخطط، الذي تتوقع Echo IQ تقديمه خلال الأسابيع المقبلة. تخطط الشركة لاستغلال حضورها في الولايات المتحدة لتعزيز الاعتماد إذا تم تحقيق موافقة FDA. من المقرر عقد ندوة إلكترونية في 26 نوفمبر 2025 الساعة 11:00 صباحاً بتوقيت AEDT.
- Sensitivity 99.5% on independent 17,000-study dataset
- Specificity 91.0% indicating strong true-negative detection
- Validation completed — final clinical step before FDA 510(k)
- FDA clearance pending; submission expected but not yet granted
- Estimated false-positive rate ~9% (specificity 91.0%)
- Clinical validation successfully completed with Mayo Clinic Platform’s Validate program – marking the final clinical requirement prior to FDA 510(k) submission
- EchoSolv HF validation met the primary endpoint, delivering performance exceeding company expectations in detecting heart failure on an independent dataset
- Study was undertaken across 17,000 individual patient echocardiograms from the Mayo Clinic Platform with results highlighting:
- Sensitivity of
99.5% , accurately identifying true positives - Specificity of
91.0% , detecting true negatives
- Sensitivity of
- FDA 510(k) submission now being finalised with lodgement expected in the coming weeks
- Company to leverage existing footprint in the US market to drive uptake of EchoSolv HF post potential FDA clearance
- FDA clearance of EchoSolv HF would unlock a major market opportunity in the US:
- Only
50% of heart failure cases are accurately diagnosed - Heart failure is the leading cause of rehospitalisation and accounts for
17% of US healthcare expenditure - Total addressable market in the US is US
$60B n o - Estimated that 1 in 4 Americans will develop heart failure in their lifetime
- Only
- Webinar scheduled for Wednesday, 26 November at 11:00am (AEDT)
SYDNEY, Nov. 24, 2025 (GLOBE NEWSWIRE) -- AI and Medical Technology Company Echo IQ Limited (ASX: EIQ) (“Echo IQ” or “the Company”) is pleased to advise that it has completed its clinical validation for its heart failure clinical decision support software (“EchoSolv HF”) in collaboration with the Mayo Clinic Platform (“MCP”), a division of the Mayo Clinic, a top ranked US hospital. The MCP Validate program is a unique in-market AI evaluation program which generates an independent and objective report on accuracy, efficacy and susceptibility to bias for AI-based decision software (refer ASX Announcement 1 July 2025).
The clinical validation was designed to evaluate the EchoSolv HF model’s ability to detect heart failure on an independent dataset of ~17,000 individual echocardiogram studies. In a major milestone, the primary endpoint of the clinical validation has been met, with results exceeding expectations.
The study results show that EchoSolv HF demonstrated outstanding performance in identifying patients with heart failure, achieving a sensitivity of
Completion of the clinical validation marks the final clinical requirement prior to a formal submission for clearance by the US Food & Drug Administration (“FDA”).
Echo IQ is now in the process of completing its formal submission to advance the clearance of EchoSolv HF via the FDA’s 510(k) regulatory pathway. The Company expects to lodge this submission in the coming weeks.
FDA clearance of the solution would allow for EchoSolv HF to be marketed to and used by healthcare professionals in the USA as a clinical decision support software to aid in the detection of heart failure.
Heart failure is the leading cause for rehospitalisation in the US and accounts for
Upon potential FDA clearance of the solution, the Company intends to leverage its existing footprint in the US market to drive uptake of EchoSolv HF.
Webinar:
Echo IQ will host a webinar at 11:00am AEDT on Wednesday, 26 November 2025 during which CEO, Mr Dustin Haines will provide an overview of this development. Recently appointed US Head of Commercial, Mr Nick Lubbers will also present an update to investors on the Company’s progress in the US market. The briefing will be followed by a Q&A Session. Questions can be submitted now to investors@echoiq.ai.
Anyone wishing to attend the webinar must register in advance, using the link below:
Date and time: 11:00am AEDT (8:00am AWST) on Wednesday, 26 November 2025
Register via: https://us02web.zoom.us/webinar/register/WN_PlLK4Ch4Say6Ahv_cDukqw#/registration
Management commentary:
Chief Executive Officer, Mr Dustin Haines, said: “Completion of this clinical validation study represents a major milestone in the commercialisation of EchoSolv HF. The independent confirmation of our model’s accuracy and reliability through the Mayo Clinic Platform’s Validate program have exceeded internal expectations and provides strong objective evidence supporting the clinical utility of EchoSolv HF in real-world settings, particularly compared to existing diagnostic tools being utilised across the US. This clinical validation sets Echo IQ on a path to deliver category leading evidence for supporting clinicians in diagnosing heart failure accurately, earlier and more confidently.”
With this final clinical requirement now complete, our focus shifts to lodging the formal FDA submission in the coming weeks. Gaining clearance will enable clinicians across the US to use EchoSolv HF as a powerful decision support software to improve the early and accurate detection of heart failure – a condition that remains significantly under-diagnosed and under-treated. We look forward to advancing this next phase and to working closely with healthcare partners as we prepare for a full commercial rollout.”
Authorised for release by the Board of Directors of Echo IQ Limited.
| Investor Enquiries: | |
| Andrew Grover, Executive Chair | Henry Jordan, Six Degrees Investor Relations |
| Andrew.grover@echoiq.ai / investor@echoiq.ai | Henry.jordan@sdir.com.au / +61 (0) 431 271 538 |
ABOUT ECHO IQ
Echo IQ uses AI-driven technology and proprietary software to improve decision making in Cardiology. The company is based in Sydney, Australia.
FORWARD-LOOKING STATEMENTS:
This announcement contains forward-looking statements regarding Echo IQ’s expectations, intentions, and projections regarding future events, including statements about FDA 510(k) submission timing, potential FDA clearance of EchoSolv HF, commercialisation plans, market opportunities, and expected product performance. These forward-looking statements are based on current expectations and assumptions and are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied by such statements.
Key risks and uncertainties include, but are not limited to: the timing and outcome of the FDA 510(k) review process, which is uncertain and may result in delays, requests for additional information, or denial of clearance; regulatory requirements that may change or differ from expectations; the ability to successfully commercialise EchoSolv HF in the US market; market acceptance by healthcare professionals and institutions; competitive factors and the development of alternative technologies; reimbursement policies and healthcare spending trends; and the Company’s ability to execute its commercialisation strategy. The Company’s ability to achieve the market opportunities described in this announcement is subject to numerous factors beyond its control.
Actual results, performance, or achievements may differ materially from those expressed or implied in forward-looking statements. Echo IQ does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law or ASX Listing Rules. Investors are cautioned not to place undue reliance on forward-looking statements.
i https://academic.oup.com/cardiovascres/article/118/17/3272/6527627?login=false#google_vignette
ii https://pmc.ncbi.nlm.nih.gov/articles/PMC9070116/
iii https://hfstats.org/stat-category/incidence-prevalence-and-lifetime-risk-estimates-of-hf-in-the-us/
FAQ
What were EchoSolv HF clinical validation results for EIQ (ASX:EIQ) on November 24, 2025?
When will Echo IQ lodge the FDA 510(k) submission for EchoSolv HF (ASX:EIQ)?
How large was the dataset used in the Mayo Clinic Platform validation of EchoSolv HF?
What does EchoSolv HF's specificity of 91.0% mean for patients and clinicians?
Will EchoSolv HF be available in the US immediately after the November 24, 2025 validation?
When is the investor webinar on EchoSolv HF results for Echo IQ (ASX:EIQ)?
