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HeartSciences' AI-ECG Algorithms Assigned CMS Medicare and Medicaid Reimbursement

HeartSciences' AI-ECG Algorithms Assigned CMS Medicare and Medicaid Reimbursement

HeartSciences的人工智能心電圖算法獲得了康哲藥業的醫療保險和醫療補助報銷。
GlobeNewswire ·  11/13 22:00

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 $125.

德克薩斯州南湖,2024年11月13日(環球新聞) -- 醫心科技有限公司,註冊商號爲Heart Test Laboratories, Inc.,證券代碼爲納斯達克: HSCS;HSCSW,又稱HeartSciences(下稱「本公司」)是一家以人工智能爲核心的醫療科技公司,專注於通過對心臟疾病的早期檢測來挽救生命,致力於將ECG(又稱爲EKG)變得更加有臨床價值。每週有數百萬份ECG檢查,該公司的宗旨是通過使其成爲更有價值的心臟篩查工具,特別是在前線或臨床現場,改善醫療保健。HeartSciences擁有最大的人工智能-ECG算法庫之一,正在開發可在硬體無關的基於雲的平台上或其專有的MyoVista wavECG設備上提供的AI-ECG解決方案,以幫助全球各種醫療機構在合適的環境下診斷心血管疾病。HeartSciences的FDA覈准申請的第一項產品候選人MyoVista wavECG(簡稱MyoVista)是一項靜息狀態的12導聯心電圖,也旨在提供傳統的心電圖信息,並在同一檢查中提供與心臟功能障礙相關的診斷信息,這在傳統上只能通過使用心臟成像技術獲得。 以HeartSciences(納斯達克:HSCS;HSCSW)名稱經營("HeartSciences"或"公司")的人工智能(人工智能)驅動的醫療科技公司,專注於通過早期檢測心臟病來改變心電圖/心電描記(ECGs/EKGs),以拯救生命。今天宣佈,醫療保險和醫療補助服務中心(康哲藥業)已將人工智能心電圖技術納入2025年醫院門診前景支付系統(OPPS)最終規則,分配APC 5734。此批准將允許門診設置在FDA獲准後爲HeartSciences的MyoVista wavECGTm算法和MyoVista InsightsTm低射血分數算法獲得報銷。預計支付率爲125美元。

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."

HeartSciences首席執行官安德魯·西普森(Andrew Simpson)表示:"康哲藥業對人工智能心電圖的報銷的納入,代表了我們產品商業化的一個重要里程碑,進一步驗證了巨大的市場機會,尤其考慮到心電圖在臨床實踐中的廣泛使用。我們期待向FDA提交申請,並在2025年將我們的MyoVista wavECG和MyoVista Insights平台推向市場。"

About HeartSciences

關於醫心科技公司

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.

Heart Test Laboratories,Inc.,即HeartSciences,是一家醫療科技公司,專注於將創新的基於人工智能技術應用於心電圖(也稱爲心電圖),以擴展和改善心電圖的臨床效用。每週進行數百萬次心電圖檢查,公司的目標是通過使其成爲一個更有價值的心臟篩查工具,特別是在一線或基層臨床環境中,來改善醫療保健。HeartSciences擁有最大的人工智能心電圖算法庫之一,並正在開發AI-ECG解決方案,可在硬件不可知的基於雲的平台或其專有的MyoVista wavECG設備上提供,以幫助在全球任何護理環境中以最適合不同醫護人員的方式識別心血管疾病。HeartSciences的FDA清除首個產品候選人,即MyoVista wavECG或MyoVista,是一款休息12導聯心電圖,旨在提供與心臟功能障礙相關的診斷信息,這些信息傳統上僅能通過心臟成像來獲得。MyoVista還提供同一測試中的常規心電圖信息。

For more information, please visit: . X: @HeartSciences

更多信息,請訪問:@HeartSciences X。

Safe Harbor Statement

Safe Harbor聲明

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.

本公告包含根據1933年證券法修正案第27A條和1934年證券交易法修正案第21E條的前瞻性聲明。這些前瞻性聲明是根據1995年《私人證券訴訟改革法案》的"安全港"規定進行的,並涉及公司未來的財務和經營業績。本公告所包含的所有陳述,除了歷史事實陳述外,均爲"前瞻性聲明",包括但不限於有關HeartSciences信念和期望的陳述。這些陳述基於當前的期望、假設和涉及對未來經濟、競爭和市場條件以及未來業務決策的判斷的不確定性,這些判斷都很難或幾乎不可能準確預測,而其中許多又超出了公司的控制範圍。這些前瞻性聲明所反映的期望涉及重大假設、風險和不確定性,這些期望可能被證明是不正確的。投資者不應過分依賴這些前瞻性聲明,這些聲明僅於本新聞稿發佈之日有效。潛在的風險和不確定性包括但不限於,在2024年4月30日結束的財年的HeartSciences提交給美國證券交易委員會("SEC")的10-k表的風險,在2024年7月29日提交給SEC的財季結束於2024年7月31日的HeartSciences 10-Q表中討論的風險,以及HeartSciences在www.sec.gov提交給SEC的其他文件中討論的風險。除了在證券法規要求的情況下,公司不承擔更新這些前瞻性聲明的責任。

Contacts:

聯繫人:

HeartSciences
Gene Gephart
+1-682-244-2578
info@heartsciences.com

HeartSciences
Gene Gephart
+1-682-244-2578
info@heartsciences.com

Investors
Gilmartin Group
Vivian Cervantes
investorrelations@heartsciences.com

投資者
吉爾馬丁集團
Vivian Cervantes
investorrelations@heartsciences.com


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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