HeartSciences’ AI-ECG Algorithms Assigned CMS Medicare and Medicaid Reimbursement
HeartSciences (NASDAQ: HSCS) announces that the Centers for Medicare & Medicaid Services (CMS) has included AI-ECG technology in the 2025 Hospital Outpatient Prospective Payment System final rule under APC 5734. This approval will enable outpatient settings to receive $125 reimbursement for HeartSciences' MyoVista® wavECGTM algorithm and MyoVista® InsightsTM low ejection fraction algorithm, pending FDA clearance. The company plans to submit both platforms to the FDA and launch them in 2025.
HeartSciences (NASDAQ: HSCS) annuncia che i Centri per i Servizi Medicare e Medicaid (CMS) hanno incluso la tecnologia AI-ECG nella regola finale del Sistema di Pagamento Prospective per i Pazienti Ospedalieri del 2025 sotto APC 5734. Questa approvazione permetterà ai centri ambulatoriali di ricevere un rimborso di $125 per l'algoritmo wavECGTM di MyoVista® e l'algoritmo di bassa frazione di gittata MyoVista® InsightsTM, in attesa dell'approvazione della FDA. L'azienda prevede di presentare entrambe le piattaforme alla FDA e di lanciarle nel 2025.
HeartSciences (NASDAQ: HSCS) anuncia que los Centros de Servicios de Medicare y Medicaid (CMS) han incluido la tecnología AI-ECG en la regla final del Sistema de Pago Prospectivo para Pacientes Ambulatorios de 2025 bajo APC 5734. Esta aprobación permitirá que los centros ambulatorios reciban un reembolso de $125 por el algoritmo wavECGTM de MyoVista® y el algoritmo de baja fracción de eyección MyoVista® InsightsTM, sujeto a la autorización de la FDA. La empresa tiene planes de presentar ambas plataformas a la FDA y lanzarlas en 2025.
HeartSciences (NASDAQ: HSCS)는 메디케어 및 메디케이드 서비스 센터(CMS)가 2025년 병원 외래 환자 예측 지불 시스템 최종 규칙에 AI-ECG 기술을 APC 5734로 포함시켰다고 발표했습니다. 이 승인으로 외래 환자 시설은 HeartSciences의 MyoVista® wavECGTM 알고리즘 및 MyoVista® InsightsTM 저박출 분율 알고리즘에 대해 $125의 환급을 받을 수 있게 됩니다. FDA 승인을 기다리는 중입니다. 회사는 두 플랫폼을 FDA에 제출하고 2025년에 출시할 계획입니다.
HeartSciences (NASDAQ: HSCS) annonce que les Centres des services Medicare et Medicaid (CMS) ont inclus la technologie AI-ECG dans la règle finale du Système de paiement prospectif pour les patients hospitalisés de 2025 sous APC 5734. Cette approbation permettra aux établissements ambulatoires de recevoir un remboursement de 125 $ pour l'algorithme wavECGTM de MyoVista® et l'algorithme de faible fraction d'éjection MyoVista® InsightsTM, en attente de l'autorisation de la FDA. L'entreprise prévoit de soumettre les deux plateformes à la FDA et de les lancer en 2025.
HeartSciences (NASDAQ: HSCS) gibt bekannt, dass die Centers for Medicare & Medicaid Services (CMS) die AI-ECG-Technologie in die endgültige Regelung des Prospektiven Zahlungssystems für Krankenhaus-Ambulanzleistungen 2025 unter APC 5734 aufgenommen haben. Diese Genehmigung wird es Ambulanzzentren ermöglichen, $125 Erstattung für den MyoVista® wavECGTM-Algorithmus und den MyoVista® InsightsTM-Algorithmus mit niedriger Auswurfquote zu erhalten, vorbehaltlich der Genehmigung durch die FDA. Das Unternehmen plant, beide Plattformen bei der FDA einzureichen und sie 2025 auf den Markt zu bringen.
- CMS approval for Medicare/Medicaid reimbursement secured
- Established reimbursement rate of $125 per procedure
- Clear path for commercialization in outpatient settings
- Products still pending FDA clearance
- Revenue generation dependent on 2025 regulatory approval
Insights
The CMS reimbursement approval for HeartSciences' AI-ECG technology represents a significant commercial milestone. With a
The ECG market has substantial potential, with over 250 million ECGs performed annually in the US alone. AI-enhanced ECGs that can detect heart conditions earlier could capture a meaningful share of this market. The reimbursement approval signals strong potential for market penetration, particularly in the large outpatient segment where cost recovery is a key adoption factor.
However, success still hinges on achieving FDA clearance for both the wavECG and Insights platforms, targeted for 2025. The company's small market cap of
Southlake, TX, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that the Centers for Medicare & Medicaid Services (CMS) has included AI-ECG technology in the 2025 Hospital Outpatient Prospective Payment System (OPPS) final rule under assignment APC 5734. This approval would allow outpatient settings to receive reimbursement for HeartSciences’ MyoVista® wavECGTM algorithm and MyoVista® InsightsTM low ejection fraction algorithm, upon FDA clearance. The payment rate is expected to be
Andrew Simpson, CEO of HeartSciences, said, “The inclusion of AI-ECG for reimbursement by CMS represents a significant milestone for commercialization of our products and further validates the enormous market opportunity, particularly given the widespread use of the ECG in clinical practice. We look forward to submitting to the FDA and bringing to market both our MyoVista wavECG and MyoVista Insights platform in 2025.”
About HeartSciences
Heart Test Laboratories, Inc. d/b/a HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve an ECG's clinical utility. Millions of ECGs are performed every week and the Company's objective is to improve healthcare by making it a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences has one of the largest libraries of AI-ECG algorithms and is developing AI-ECG solutions to be made available on either a hardware agnostic cloud-based platform or its proprietary MyoVista® wavECG™ device, to help identify cardiovascular disease in any care setting worldwide in a manner to best suit different care providers. HeartSciences' first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test.
For more information, please visit: https://heartsciences.com/. X: @HeartSciences
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company's future financial and operating performance. All statements, other than statements of historical facts, included herein are "forward-looking statements" including, among other things, statements about HeartSciences' beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences' Annual Report on Form 10-K for the fiscal year ended April 30, 2024, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 29, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2024, filed with the SEC on September 12, 2024 and in HeartSciences' other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
Contacts:
HeartSciences
Gene Gephart
+1-682-244-2578
info@heartsciences.com
Investors
Gilmartin Group
Vivian Cervantes
investorrelations@heartsciences.com
FAQ
What is the CMS reimbursement rate for HeartSciences (HSCS) AI-ECG technology?
When will HeartSciences (HSCS) launch its MyoVista platforms?
What products are covered under the new CMS reimbursement for HeartSciences (HSCS)?
