{"success":true,"data":{"pressRelease":{"id":"161836","rtpr_id":"nGNX7Gd73S-20261006","ticker":"HSCS","exchange":"NASDAQ","all_tickers":["HSCS","HSCSW"],"title":"HeartSciences Receives FDA 510(k) Clearance for its MyoVista® wavECGTM Device","author":"Globe Newswire","published_at":"2026-10-06T12:30:00.638Z","article_body":"Southlake, TX, Oct. 06, 2026 (GLOBE NEWSWIRE) -- HeartSciences Inc.\n(https://www.globenewswire.com/Tracker?data=Bl0QS_s62ph5YdqVZFCHu9HVSsSTw6TeaSSIN4mRhB1nXz8r_XYI63YTMTcUPf-h46A89SYzSlbrqNwZ0qAkRu5BynaD6Yqm6CZRa20kKlA=) (Nasdaq:\nHSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare\ninformation technology (“HIT”) company focused on advancing\nelectrocardiography (“ECG” or “EKG”) through the integration of\nartificial intelligence (“AI”), today announced that the U.S. Food and\nDrug Administration (“FDA”) has granted 510(k) clearance (K260005) for its\nMyoVista® wavECG(TM) device as a 12-lead resting electrocardiograph. The\nclearance covers the acquisition and interpretation of ECG signals from adult\nand pediatric patients in hospitals and healthcare facilities, with\ninterpretive statements provided to clinicians on an advisory basis. The\nclearance does not include an AI-ECG algorithm.\n\nAs previously reported, HeartSciences separated the FDA submissions for the\nMyoVista wavECG device and its impaired cardiac relaxation AI-ECG algorithm\nfollowing updated guidance published by the American Society of\nEchocardiography regarding the assessment of left ventricular diastolic\ndysfunction. The Company does not intend to commercialize the device without a\ncleared AI-ECG algorithm and has made no commitment to, and has no timeline\nfor, commercialization of the device. The clearance does, however, broaden the\npotential options available to the Company for the device and its related\nintellectual property, which the Company intends to evaluate.\n\nAndrew Simpson, CEO of HeartSciences, said, “This clearance is the result of\nseveral years of work by our clinical, regulatory and engineering teams, and I\nwant to thank them for the quality and persistence of that effort. Our\ncommercial focus remains on MyoVista Insights, but clearance makes the device\nand the intellectual property behind it a more readily realizable asset, and\nwe will take the time to consider the best route to realizing that value.”\n\nProposed Transaction with Fortitude\n\nThe proposed business combination with Fortitude Mining Holdings, Inc.\n(“Fortitude”), announced in June 2026 (the “Proposed Transaction”),\ncontinues to progress. The Company expects to close the Proposed Transaction\nin Q4 calendar 2026, subject to customary closing conditions, including\napproval by HeartSciences’ shareholders.\n\nAbout HeartSciences\n\nHeartSciences is a healthcare information technology company advancing the use\nof ECG/EKGs through the integration of artificial intelligence.\nHeartSciences’ MyoVista Insights™ Platform is a cloud-native, vendor- and\ndevice-agnostic ECG management system designed to modernize ECG workflows and\nimprove clinical efficiency and decision-making. The platform’s AI-ECG\nmarketplace is designed to deliver AI-ECG algorithms into clinical workflows\nacross a health system’s existing ECG equipment.\n\nFor more information, please visit www.heartsciences.com and follow\nHeartSciences on X @HeartSciences.\n\nAbout Fortitude\n\nFortitude, currently wholly-owned by Digital Currency Group, Inc. (“DCG”),\nis an institutional-scale, vertically integrated venture mining platform\noperating across the Proof-of-Work ecosystem and anchored in Zcash. Fortitude\npairs self-mining operations with an owned data center footprint, a\ndiversified power portfolio backed by competitive long-term contracts, and\ndisciplined capital allocation to identify and scale high-conviction\nopportunities in emerging Proof-of-Work ecosystems, beginning with its\nleadership position in the Zcash network. Fortitude is led by an experienced\nteam of operators, capital markets professionals, and digital asset\nspecialists with a track record of identifying and scaling high-conviction\nopportunities and building privacy-preserving digital asset infrastructure.\n\nFor more information, visit www.fortitudemining.com and follow Fortitude on\nX at @FortitudeCrypto.\n\nIn the ordinary course of business, Fortitude currently sells or otherwise\nmonetizes all the digital assets that it mines, including ZEC. In addition,\nFortitude and its affiliates and subsidiaries, including DCG, from time to\ntime sell, pledge or otherwise monetize their digital asset holdings,\nincluding ZEC. The funds received from such sales, pledges, or other\nmonetization activities are used to fund operating expenses and capital\ninvestments, as well as for other purposes, including to hedge exposures and\nrealize investment gains.\n\nCautionary Note Regarding Forward-Looking Information\n\nThis press release may contain forward-looking statements concerning\nHeartSciences, Fortitude and the Proposed Transaction and other matters. These\nforward-looking statements generally can be identified by the use of words\nsuch as “aim,” “anticipate,” “expect,” “plan,” “could,”\n“may,” “will,” “believe,” “estimate,” “forecast,”\n“goal,” “project,” “potential,” “target,” “objective,”\n“intend,” and other words of similar meaning, but the absence of these\nwords does not mean that a statement is not forward-looking. All statements\nHeartSciences and/or Fortitude make in communications that do not relate to\nmatters of historical fact should be considered forward-looking statements.\n\nThese forward-looking statements are based on management’s current\nexpectations and assumptions as of the date of this press release and are\nsubject to a number of known and unknown risks, uncertainties, and other\nfactors that could cause actual results to differ materially from those\nexpressed or implied by such statements, which may include, without\nlimitation, the following: the risk that the Proposed Transaction may not be\ncompleted on the anticipated timeline or at all; the failure to satisfy the\nconditions to the closing of the Proposed Transaction, including obtaining the\nrequisite approval of HeartSciences’ shareholders; market, macroeconomic, or\nother conditions that could adversely affect either HeartSciences or\nFortitude, or the combined company; risks related to the integration of the\ntwo companies and the management of a newly public company; risks relating to\nFortitude’s operations and business, including the highly volatile nature of\nthe price of Zcash and other cryptocurrencies; risks relating to significant\nlegal, commercial, regulatory and technical uncertainty regarding digital\nassets generally; risks relating to the commercialization of MyoVista\nInsights(TM), including the rate of adoption by healthcare providers and the\nconversion of agreements into revenue; and risks relating to the MyoVista\nwavECG device, including the Company’s ability to realize value from the\ndevice and related intellectual property, and the recoverability of the\nrelated inventory. Additional factors that may cause actual results to differ\nmaterially from those expressed or implied by the forward-looking statements\nin this press release are discussed in HeartSciences’ amended preliminary\nproxy statement on Schedule 14A, filed with the U.S. Securities and Exchange\nCommission (the “SEC”) on October 6, 2026, in connection with the Proposed\nTransaction (the “Preliminary Proxy Statement”), HeartSciences’ 2026\nAnnual Report on Form 10-K, filed with the SEC on July 23, 2026,\nHeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended\nJuly 31, 2026, filed with the SEC on September 14, 2026, and its other reports\nfiled with the SEC from time to time. Readers are cautioned not to place undue\nreliance on these forward-looking statements. Each of HeartSciences and\nFortitude expressly disclaims any obligation to update or revise any\nforward-looking statements, whether as a result of new information, future\nevents, or otherwise, except as required by applicable law. All\nforward-looking statements are made as of the date of this press release.\n\nAdditional Information About the Proposed Transaction and Where to Find It\n\nThis press release may be deemed solicitation material in respect of the\nProposed Transaction. In connection with the Proposed Transaction,\nHeartSciences has filed the Preliminary Proxy Statement and may file\nadditional relevant materials with the SEC. Following the filing of a\ndefinitive proxy statement with the SEC, HeartSciences will mail the\ndefinitive proxy statement and a proxy card to each shareholder entitled to\nvote at the special meeting relating to the Proposed Transaction. INVESTORS\nAND SHAREHOLDERS OF HEARTSCIENCES ARE URGED TO READ THESE MATERIALS (INCLUDING\nANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN\nCONNECTION WITH THE PROPOSED TRANSACTION THAT HEARTSCIENCES HAS FILED OR MAY\nFILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN IMPORTANT\nINFORMATION ABOUT HEARTSCIENCES AND THE PROPOSED TRANSACTION. THIS PRESS\nRELEASE DOES NOT CONTAIN ALL THE INFORMATION THAT SHOULD BE CONSIDERED\nCONCERNING THE PROPOSED TRANSACTION AND RELATED MATTERS AND IS NOT INTENDED TO\nPROVIDE THE BASIS FOR ANY INVESTMENT DECISION OR ANY OTHER DECISION IN RESPECT\nOF SUCH MATTERS. The Preliminary Proxy Statement, the definitive proxy\nstatement and other relevant materials in connection with the Proposed\nTransaction (when they become available), and any other documents filed by\nHeartSciences with the SEC, may be obtained free of charge at the SEC’s\nwebsite at www.sec.gov. In addition, investors and shareholders may obtain\nfree copies of the documents filed with the SEC by sending a request to the\nHeartSciences Investor Relations Department\nat investorrelations@heartsciences.com.\n\nParticipants in the Solicitation\n\nHeartSciences and Fortitude, their respective directors and executive\nofficers, and certain executive officers of DCG may be deemed to be\nparticipants in the solicitation of proxies from HeartSciences’ shareholders\nwith respect to the Proposed Transaction. Information regarding the identity\nof the potential participants, and their direct or indirect interests in the\nProposed Transaction, by security holdings or otherwise, is set forth in the\nPreliminary Proxy Statement and other materials have been or may be filed with\nthe SEC in connection with the Proposed Transaction.\n\nNo Offer or Solicitation\n\nAny information contained herein is not intended to and does not constitute,\nor form part of, an offer, invitation or the solicitation of an offer or\ninvitation to purchase, otherwise acquire, subscribe for, sell or otherwise\ndispose of any securities, or the solicitation of any vote or approval in any\njurisdiction, pursuant to the Proposed Transaction or otherwise, nor shall\nthere be any sale, issuance or transfer of securities in any jurisdiction in\ncontravention of applicable law. The Proposed Transaction will be implemented\nsolely pursuant to the terms and conditions of the merger agreement, which\ncontain the full terms and conditions of the Proposed Transaction.\n\nInvestor Relations and Media Contacts:\nHeartSciences\nIntegrous Communications\nMark Komonoski\nPhone: 877-255-8483\nEmail: mkomonoski@integcom.us\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/800a6aae-74f3-42bb-9199-5e169ed9b881)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX7Gd73S-20261006","title":"HeartSciences Receives FDA 510(k) Clearance for its MyoVista® wavECGTM Device","author":"Globe Newswire","ticker":"HSCS","created":"2026-10-06T12:30:00.638Z","tickers":["HSCS","HSCSW"],"exchange":"NASDAQ","article_body":"Southlake, TX, Oct. 06, 2026 (GLOBE NEWSWIRE) -- HeartSciences Inc.\n(https://www.globenewswire.com/Tracker?data=Bl0QS_s62ph5YdqVZFCHu9HVSsSTw6TeaSSIN4mRhB1nXz8r_XYI63YTMTcUPf-h46A89SYzSlbrqNwZ0qAkRu5BynaD6Yqm6CZRa20kKlA=) (Nasdaq:\nHSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare\ninformation technology (“HIT”) company focused on advancing\nelectrocardiography (“ECG” or “EKG”) through the integration of\nartificial intelligence (“AI”), today announced that the U.S. Food and\nDrug Administration (“FDA”) has granted 510(k) clearance (K260005) for its\nMyoVista® wavECG(TM) device as a 12-lead resting electrocardiograph. The\nclearance covers the acquisition and interpretation of ECG signals from adult\nand pediatric patients in hospitals and healthcare facilities, with\ninterpretive statements provided to clinicians on an advisory basis. The\nclearance does not include an AI-ECG algorithm.\n\nAs previously reported, HeartSciences separated the FDA submissions for the\nMyoVista wavECG device and its impaired cardiac relaxation AI-ECG algorithm\nfollowing updated guidance published by the American Society of\nEchocardiography regarding the assessment of left ventricular diastolic\ndysfunction. The Company does not intend to commercialize the device without a\ncleared AI-ECG algorithm and has made no commitment to, and has no timeline\nfor, commercialization of the device. The clearance does, however, broaden the\npotential options available to the Company for the device and its related\nintellectual property, which the Company intends to evaluate.\n\nAndrew Simpson, CEO of HeartSciences, said, “This clearance is the result of\nseveral years of work by our clinical, regulatory and engineering teams, and I\nwant to thank them for the quality and persistence of that effort. Our\ncommercial focus remains on MyoVista Insights, but clearance makes the device\nand the intellectual property behind it a more readily realizable asset, and\nwe will take the time to consider the best route to realizing that value.”\n\nProposed Transaction with Fortitude\n\nThe proposed business combination with Fortitude Mining Holdings, Inc.\n(“Fortitude”), announced in June 2026 (the “Proposed Transaction”),\ncontinues to progress. The Company expects to close the Proposed Transaction\nin Q4 calendar 2026, subject to customary closing conditions, including\napproval by HeartSciences’ shareholders.\n\nAbout HeartSciences\n\nHeartSciences is a healthcare information technology company advancing the use\nof ECG/EKGs through the integration of artificial intelligence.\nHeartSciences’ MyoVista Insights™ Platform is a cloud-native, vendor- and\ndevice-agnostic ECG management system designed to modernize ECG workflows and\nimprove clinical efficiency and decision-making. The platform’s AI-ECG\nmarketplace is designed to deliver AI-ECG algorithms into clinical workflows\nacross a health system’s existing ECG equipment.\n\nFor more information, please visit www.heartsciences.com and follow\nHeartSciences on X @HeartSciences.\n\nAbout Fortitude\n\nFortitude, currently wholly-owned by Digital Currency Group, Inc. (“DCG”),\nis an institutional-scale, vertically integrated venture mining platform\noperating across the Proof-of-Work ecosystem and anchored in Zcash. Fortitude\npairs self-mining operations with an owned data center footprint, a\ndiversified power portfolio backed by competitive long-term contracts, and\ndisciplined capital allocation to identify and scale high-conviction\nopportunities in emerging Proof-of-Work ecosystems, beginning with its\nleadership position in the Zcash network. Fortitude is led by an experienced\nteam of operators, capital markets professionals, and digital asset\nspecialists with a track record of identifying and scaling high-conviction\nopportunities and building privacy-preserving digital asset infrastructure.\n\nFor more information, visit www.fortitudemining.com and follow Fortitude on\nX at @FortitudeCrypto.\n\nIn the ordinary course of business, Fortitude currently sells or otherwise\nmonetizes all the digital assets that it mines, including ZEC. In addition,\nFortitude and its affiliates and subsidiaries, including DCG, from time to\ntime sell, pledge or otherwise monetize their digital asset holdings,\nincluding ZEC. The funds received from such sales, pledges, or other\nmonetization activities are used to fund operating expenses and capital\ninvestments, as well as for other purposes, including to hedge exposures and\nrealize investment gains.\n\nCautionary Note Regarding Forward-Looking Information\n\nThis press release may contain forward-looking statements concerning\nHeartSciences, Fortitude and the Proposed Transaction and other matters. These\nforward-looking statements generally can be identified by the use of words\nsuch as “aim,” “anticipate,” “expect,” “plan,” “could,”\n“may,” “will,” “believe,” “estimate,” “forecast,”\n“goal,” “project,” “potential,” “target,” “objective,”\n“intend,” and other words of similar meaning, but the absence of these\nwords does not mean that a statement is not forward-looking. All statements\nHeartSciences and/or Fortitude make in communications that do not relate to\nmatters of historical fact should be considered forward-looking statements.\n\nThese forward-looking statements are based on management’s current\nexpectations and assumptions as of the date of this press release and are\nsubject to a number of known and unknown risks, uncertainties, and other\nfactors that could cause actual results to differ materially from those\nexpressed or implied by such statements, which may include, without\nlimitation, the following: the risk that the Proposed Transaction may not be\ncompleted on the anticipated timeline or at all; the failure to satisfy the\nconditions to the closing of the Proposed Transaction, including obtaining the\nrequisite approval of HeartSciences’ shareholders; market, macroeconomic, or\nother conditions that could adversely affect either HeartSciences or\nFortitude, or the combined company; risks related to the integration of the\ntwo companies and the management of a newly public company; risks relating to\nFortitude’s operations and business, including the highly volatile nature of\nthe price of Zcash and other cryptocurrencies; risks relating to significant\nlegal, commercial, regulatory and technical uncertainty regarding digital\nassets generally; risks relating to the commercialization of MyoVista\nInsights(TM), including the rate of adoption by healthcare providers and the\nconversion of agreements into revenue; and risks relating to the MyoVista\nwavECG device, including the Company’s ability to realize value from the\ndevice and related intellectual property, and the recoverability of the\nrelated inventory. Additional factors that may cause actual results to differ\nmaterially from those expressed or implied by the forward-looking statements\nin this press release are discussed in HeartSciences’ amended preliminary\nproxy statement on Schedule 14A, filed with the U.S. Securities and Exchange\nCommission (the “SEC”) on October 6, 2026, in connection with the Proposed\nTransaction (the “Preliminary Proxy Statement”), HeartSciences’ 2026\nAnnual Report on Form 10-K, filed with the SEC on July 23, 2026,\nHeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended\nJuly 31, 2026, filed with the SEC on September 14, 2026, and its other reports\nfiled with the SEC from time to time. Readers are cautioned not to place undue\nreliance on these forward-looking statements. Each of HeartSciences and\nFortitude expressly disclaims any obligation to update or revise any\nforward-looking statements, whether as a result of new information, future\nevents, or otherwise, except as required by applicable law. All\nforward-looking statements are made as of the date of this press release.\n\nAdditional Information About the Proposed Transaction and Where to Find It\n\nThis press release may be deemed solicitation material in respect of the\nProposed Transaction. In connection with the Proposed Transaction,\nHeartSciences has filed the Preliminary Proxy Statement and may file\nadditional relevant materials with the SEC. Following the filing of a\ndefinitive proxy statement with the SEC, HeartSciences will mail the\ndefinitive proxy statement and a proxy card to each shareholder entitled to\nvote at the special meeting relating to the Proposed Transaction. INVESTORS\nAND SHAREHOLDERS OF HEARTSCIENCES ARE URGED TO READ THESE MATERIALS (INCLUDING\nANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN\nCONNECTION WITH THE PROPOSED TRANSACTION THAT HEARTSCIENCES HAS FILED OR MAY\nFILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN IMPORTANT\nINFORMATION ABOUT HEARTSCIENCES AND THE PROPOSED TRANSACTION. THIS PRESS\nRELEASE DOES NOT CONTAIN ALL THE INFORMATION THAT SHOULD BE CONSIDERED\nCONCERNING THE PROPOSED TRANSACTION AND RELATED MATTERS AND IS NOT INTENDED TO\nPROVIDE THE BASIS FOR ANY INVESTMENT DECISION OR ANY OTHER DECISION IN RESPECT\nOF SUCH MATTERS. The Preliminary Proxy Statement, the definitive proxy\nstatement and other relevant materials in connection with the Proposed\nTransaction (when they become available), and any other documents filed by\nHeartSciences with the SEC, may be obtained free of charge at the SEC’s\nwebsite at www.sec.gov. In addition, investors and shareholders may obtain\nfree copies of the documents filed with the SEC by sending a request to the\nHeartSciences Investor Relations Department\nat investorrelations@heartsciences.com.\n\nParticipants in the Solicitation\n\nHeartSciences and Fortitude, their respective directors and executive\nofficers, and certain executive officers of DCG may be deemed to be\nparticipants in the solicitation of proxies from HeartSciences’ shareholders\nwith respect to the Proposed Transaction. Information regarding the identity\nof the potential participants, and their direct or indirect interests in the\nProposed Transaction, by security holdings or otherwise, is set forth in the\nPreliminary Proxy Statement and other materials have been or may be filed with\nthe SEC in connection with the Proposed Transaction.\n\nNo Offer or Solicitation\n\nAny information contained herein is not intended to and does not constitute,\nor form part of, an offer, invitation or the solicitation of an offer or\ninvitation to purchase, otherwise acquire, subscribe for, sell or otherwise\ndispose of any securities, or the solicitation of any vote or approval in any\njurisdiction, pursuant to the Proposed Transaction or otherwise, nor shall\nthere be any sale, issuance or transfer of securities in any jurisdiction in\ncontravention of applicable law. The Proposed Transaction will be implemented\nsolely pursuant to the terms and conditions of the merger agreement, which\ncontain the full terms and conditions of the Proposed Transaction.\n\nInvestor Relations and Media Contacts:\nHeartSciences\nIntegrous Communications\nMark Komonoski\nPhone: 877-255-8483\nEmail: mkomonoski@integcom.us\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/800a6aae-74f3-42bb-9199-5e169ed9b881)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-06T12:30:00.935629723Z","server_sent_at_ms":1791289800935},"received_at":"2026-10-06T12:30:00.987Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}