Cardiac Biotech Solutions, Inc. Secures Health Canada License for MyCardia AT Device, Now Branded as CardioHolter AT
Cardiac Biotech Solutions (OTCID: CBSC) has secured a Medical Device License from Health Canada for its MyCardia AT device, now rebranded as CardioHolter AT. The company's Canadian distributor, Your Heart Protector Corp., has placed an initial $375,000 USD order for 1,000 devices.
The CardioHolter AT will be manufactured and distributed through CBSC's partner Nasiff Associates, operating under ISO 13485 certification. The company has implemented a monthly rental program generating recurring revenue through device access, AWS Cloud-based monitoring platform, and mobile applications.
CBSC has already obtained regulatory clearance in the United States and is pursuing approval in China, advancing its global commercialization strategy for the cardiac monitoring platform.
Cardiac Biotech Solutions (OTCID: CBSC) ha ottenuto una licenza per dispositivi medici da Health Canada per il suo dispositivo MyCardia AT, ora rinominato CardioHolter AT. Il distributore canadese dell'azienda, Your Heart Protector Corp., ha effettuato un ordine iniziale di $375,000 USD per 1.000 dispositivi.
Il CardioHolter AT sarà fabbricato e distribuito tramite il partner di CBSC, Nasiff Associates, che opera con certificazione ISO 13485. L'azienda ha implementato un programma di noleggio mensile che genera entrate ricorrenti attraverso l'accesso al dispositivo, la piattaforma di monitoraggio basata su AWS Cloud e le applicazioni mobili.
CBSC ha già ottenuto l'autorizzazione regolamentare negli Stati Uniti e sta perseguendo l'approvazione in Cina, avanzando la propria strategia di commercializzazione globale della piattaforma di monitoraggio cardiaco.
Cardiac Biotech Solutions (OTCID: CBSC) ha obtenido una Licencia de Dispositivo Médico de Health Canada para su dispositivo MyCardia AT, ahora rebautizado como CardioHolter AT. El distribuidor canadiense de la empresa, Your Heart Protector Corp., ha realizado un pedido inicial de $375,000 USD para 1.000 dispositivos.
El CardioHolter AT será fabricado y distribuido a través de Nasiff Associates, socio de CBSC, que opera bajo la certificación ISO 13485. La compañía ha implementado un programa de alquiler mensual que genera ingresos recurrentes mediante el acceso al dispositivo, la plataforma de monitoreo basada en AWS Cloud y las aplicaciones móviles.
CBSC ya ha obtenido la aprobación regulatoria en Estados Unidos y está buscando la aprobación en China, avanzando su estrategia de comercialización global para la plataforma de monitoreo cardíaco.
Cardiac Biotech Solutions (OTCID: CBSC)은 Health Canada로부터 자사의 MyCardia AT 기기에 대한 의료기기 허가를 받았고, 현재 CardioHolter AT로 브랜드를 재정비했습니다. 회사의 캐나다 유통사인 Your Heart Protector Corp.은 1,000대의 기기에 대해 초기 주문 $375,000 USD를 남겼습니다.
CardioHolter AT는 Nasiff Associates와의 파트너를 통해 ISO 13485 인증 하에 제조 및 유통될 예정입니다. 회사는 디바이스 접근성, AWS 클라우드 기반 모니터링 플랫폼, 모바일 앱을 통한 recurring 수익을 창출하는 월간 대여 프로그램을 도입했습니다.
CBSC는 미국에서 이미 규제 승인을 받았으며 중국에서의 승인을 추진 중으로, 심장 모니터링 플랫폼의 글로벌 상용화 전략을 추진하고 있습니다.
Cardiac Biotech Solutions (OTCID: CBSC) a obtenu une Licence de Dispositif Médical de Health Canada pour son dispositif MyCardia AT, désormais renommé CardioHolter AT. Le distributeur canadien de l'entreprise, Your Heart Protector Corp., a passé une commande initiale de $375,000 USD pour 1 000 dispositifs.
Le CardioHolter AT sera fabriqué et distribué par le partenaire de CBSC, Nasiff Associates, opérant sous la certification ISO 13485. L'entreprise a mis en place un programme de location mensuel générant des revenus récurrents via l'accès au dispositif, la plateforme de surveillance basée sur AWS Cloud et les applications mobiles.
CBSC a déjà obtenu l'autorisation réglementaire aux États-Unis et poursuit l'approbation en Chine, avançant sa stratégie de commercialisation mondiale de la plateforme de surveillance cardiaque.
Cardiac Biotech Solutions (OTCID: CBSC) hat eine Zulassung für Medizinprodukte von Health Canada für sein MyCardia-AT-Gerät erhalten, das jetzt unter dem Namen CardioHolter AT geführt wird. Der kanadische Distributor des Unternehmens, Your Heart Protector Corp., hat eine Erstausbestellung über $375,000 USD für 1.000 Geräte aufgegeben.
Der CardioHolter AT wird durch den Partner Nasiff Associates hergestellt und vertrieben, der unter ISO 13485-Zertifizierung operiert. Das Unternehmen hat ein monatliches Mietprogramm implementiert, das durch Gerätezugang, die AWS-Cloud-basierte Monitoring-Plattform und mobile Apps wiederkehrende Einnahmen generiert.
CBSC hat bereits in den Vereinigten Staaten regulatorische Zulassungen erhalten und strebt eine Genehmigung in China an, um seine weltweite Vermarktungsstrategie für die kardiale Überwachungsplattform voranzutreiben.
Cardiac Biotech Solutions (OTCID: CBSC) حصلت على ترخيص جهاز طبي من Health Canada لجهازها MyCardia AT، وهو الآن تحت اسم CardioHolter AT. موزع الشركة في كندا، Your Heart Protector Corp.، وضع طلباً ابتدائياً بقيمة $375,000 USD لـ 1,000 جهاز.
سيتم تصنيع CardioHolter AT وتوزيعه من خلال شريك CBSC، Nasiff Associates، وفق شهادة ISO 13485. قامت الشركة بتنفيذ برنامج إيجار شهري يولد إيرادات متكررة من خلال الوصول إلى الجهاز، ومنصة المراقبة المعتمدة على سحابة AWS، والتطبيقات المحمولة.
لقد حصلت CBSC بالفعل على موافقات تنظيمية في الولايات المتحدة وتسعى للحصول على موافقة في الصين، dassها تعزز استراتيجيتها في التوسع العالمي لمنصة مراقبة القلب.
Cardiac Biotech Solutions (OTCID: CBSC) 已从加拿大卫生部获得医疗器械许可，用于其 MyCardia AT 设备，现改名为 CardioHolter AT。公司在加拿大的分销商 Your Heart Protector Corp. 已下单初始金额为 $375,000 USD，数量为 1,000 台设备。
CardioHolter AT 将通过 CBSC 的合作伙伴 Nasiff Associates 在 ISO 13485 认证下制造与分销。公司已实施 每月租赁计划，通过设备访问、基于 AWS 云的监控平台和移动应用实现持续收入。
CBSC 已在美国获得监管批准，并正在争取在中国的批准，推动其心脏监测平台的全球化商业化策略。
- Secured Health Canada Medical Device License for CardioHolter AT
- Initial order of $375,000 USD for 1,000 devices from Canadian distributor
- Established recurring revenue stream through monthly rental program
- Expanding global presence with US approval secured and China submission in progress
- Production timeline indicates 90-120 day delay for complete order fulfillment
LAS VEGAS, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Cardiac Biotech Solutions, Inc. (OTCID: CBSC) ("CBSC" or the "Company"), a designer, manufacturer, and distributor of non-invasive ambulatory cardiac monitoring products, today announced that its MyCardia AT device has been issued a Medical Device License (MDL) by Health Canada and is now approved for import into Canada, effective immediately. The device, rebranded as the CardioHolter AT, will be tested and distributed through CBSC's manufacturing partner, Nasiff Associates, located in Central Square, NY. Nasiff Associates is a Health Canada-licensed establishment operating under a certified ISO 13485 Quality Management System (QMS) that complies with Health Canada standards for Class II medical devices.
CBSC’s exclusive Canadian distributor, Your Heart Protector Corp. (Calgary, Alberta), has placed an initial order for CardioHolter AT devices totaling
In addition to revenue from device sales, CBSC has implemented a monthly rental program that provides recurring income whenever devices are deployed in hospitals and healthcare facilities. The program fees include access to the device, the AWS Cloud-based monitoring platform, and patient-facing mobile applications. Revenue from these usage fees is shared between CBSC and its distributor partners, with pricing tailored to each country’s healthcare economics and reimbursement environment.
“With Canada’s vast geography and many remote communities, there is a critical need for flexible, easy-to-use monitoring solutions that extend beyond major metropolitan areas,” said Charles Martin, Chief Executive Officer of CBSC. “The CardioHolter AT is designed to meet that need. Whether using standard landline telephone connections or newer cellular and WiFi-enabled technologies, patients can reliably transmit recorded ECG data to their physicians for timely review and diagnosis. This technology empowers physicians to achieve better patient outcomes, improved diagnoses, and enhanced quality of life regardless of a patient’s location.”
“Our company is proud to have received licensing approval from Health Canada for the CardioHolter AT device, and we look forward to launching our services in Canada,” said Elmer N. Johnson, co-owner of Your Heart Protector Corp. “We are excited to help bring this innovative device to the Canadian market, as it represents a significant advancement in remote monitoring that will provide physicians greater ability to detect, diagnose, and treat irregular heart rhythms earlier, ultimately leading to better patient outcomes.”
The Company continues to advance the global commercialization of its MyCardia AT cardiac event monitoring platform, which integrates lightweight, easy-to-use wearable technology with AWS Cloud-based connectivity and mobile applications for iOS, Android, and WeChat. With regulatory clearance already secured in the United States and Canada, and an additional submission progressing in China, CBSC’s mission is to deliver state-of-the-art cardiac monitoring solutions worldwide.
About Cardiac Biotech Solutions, Inc.
Cardiac Biotech Solutions, Inc. (CBSC) is a medical technology company dedicated to developing and commercializing advanced cardiac monitoring solutions. The Company’s flagship products, the MyCardia AT and CardioHolter AT, are next-generation cardiac event monitoring devices supported by secure, cloud-based data platforms and patient engagement tools.
About Your Heart Protector Corp.
Your Heart Protector Corp., headquartered in Calgary, Alberta, Canada, is a distributor of remote diagnostic testing medical devices and lab services technologies throughout Canada. The company specializes in innovative patient complaint, ambulatory cardiac monitoring solutions for the detection of abnormal heart rhythm reviewed by physicians in an effort to provide early diagnosis, better outcomes, and overall improved quality of life for patients.
About Nasiff Associates, Inc.
Nasiff Associates, Inc. is a medical technology company committed to providing Diagnostic PC Based ECG Solutions to Healthcare Professionals. Leading Innovation of PC Based ECG Systems used in hospitals, offices, telehealth and home-based medical services, delivering Healthcare Providers with Superior Diagnostic Computer Cardiograph Solutions. Supported by an All-American sales and support team, the Nasiff brand offers available human sales and technical support when you need it. Find uncompromised value and accurate diagnostics with Nasiff CardioCard Systems.
As additional new developments occur, Cardiac Biotech Solutions, Inc. will make timely announcements through press releases and regulatory filings to keep its shareholders, industry participants, and the public markets informed.
Company Contact Information:
Telephone: (888) 225-0870
Investor Inquiries: investor@cardiacbiotech.com
Follow CBSC: X, Facebook, Instagram, LinkedIn, YouTube, and Newsletter
This information disclosure may contain forward-looking statements covered within the meaning of the Private Securities Litigation Act of 1995. These forward-looking statements relate to, among other things, plans and timing for the introduction or enhancement of our services and products, statements about future market conditions, supply and demand conditions, and other expectations, intentions, and plans contained in this press release that are not historical fact and involve risks and uncertainties. Our expectations regarding future revenues depend upon our ability to develop and supply products and services that we may not produce today and that meet defined specifications. When used in this press release, the words "plan," "expect," "believe," and similar expressions generally identify forward-looking statements. These statements reflect our current expectations. They are subject to a number of risks and uncertainties, including, but not limited to, changes in technology and changes in pervasive markets. This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties, including, without limitation, the ability to obtain financing and regulatory and shareholder approval for anticipated actions.
FAQ
What regulatory approval did Cardiac Biotech Solutions (CBSC) receive for CardioHolter AT?
How much is the initial order value for CBSC's CardioHolter AT in Canada?
How does CBSC generate recurring revenue from CardioHolter AT?
What markets has CBSC received regulatory approval for CardioHolter AT?
Who is manufacturing the CardioHolter AT devices for CBSC?
