Cardiac Biotech Solutions, Inc. Secures Health Canada License for MyCardia AT Device, Now Branded as CardioHolter AT
MWN-AI** Summary
Cardiac Biotech Solutions, Inc. (OTCID: CBSC) has achieved a significant milestone by securing a Medical Device License (MDL) from Health Canada for its cardiac monitoring device, now branded as CardioHolter AT. This approval allows for the immediate importation and distribution of the device in Canada, a critical advancement for the company specializing in non-invasive ambulatory cardiac monitoring solutions. The CardioHolter AT will be produced in collaboration with Nasiff Associates, a Health Canada-licensed manufacturer based in New York, which adheres to strict ISO 13485 Quality Management System standards.
CBSC's exclusive Canadian distributor, Your Heart Protector Corp., has expressed confidence in the product with an initial order of $375,000, covering the first 1,000 units to be delivered after production wraps up, expected within 90–120 days. Aside from direct sales, CBSC has introduced a monthly rental program, enabling hospitals to deploy devices while generating recurring revenue. This initiative includes access to a cloud-based monitoring platform and accompanying patient mobile applications, with flexible pricing tailored to various healthcare reimbursement environments.
Charles Martin, CEO of CBSC, emphasized the importance of innovative monitoring solutions in Canada’s vast and sometimes remote regions, where reliable transmission of ECG data can greatly benefit patient care. The CardioHolter AT is designed to transmit recorded data via traditional landlines, cellular networks, or WiFi, ensuring timely medical reviews.
As the company expands its footprint globally, having already secured approvals in the U.S. and pending a submission in China, it aims to enhance diagnostic capabilities for healthcare professionals and improve patient outcomes. Overall, Cardiac Biotech Solutions is poised to make significant advancements in cardiac health monitoring with this recent Canadian licensing.
MWN-AI** Analysis
Cardiac Biotech Solutions, Inc. (CBSC) has recently made a significant stride by securing a Medical Device License from Health Canada for its MyCardia AT device, now rebranded as CardioHolter AT. This regulatory approval opens the door for the company to tap into the Canadian market, which is critical for its growth strategy particularly given the vast geography and need for effective cardiac monitoring solutions.
The strong initial order of $375,000 from Your Heart Protector Corp. signals robust demand. Moreover, CBSC’s strategy to implement a monthly rental program for devices is likely to create a steady stream of recurring revenue, which could enhance long-term financial stability. Investors should note that the integration of AWS Cloud capabilities into their monitoring platform adds a layer of value, facilitating real-time data transmission and remote monitoring. This is a major competitive advantage in the evolving healthcare landscape that favors telehealth and digital health solutions.
With regulatory clearances in both Canada and the United States, and pending approvals in China, CBSC is well-positioned for global expansion. However, potential investors should be wary of the inherent risks associated with new market entries, including compliance challenges, competitive pressures, and technology adoption rates. The company's ability to adapt its pricing and services to different healthcare environments is vital for capturing diverse markets.
In conclusion, while CBSC presents a promising investment with significant short-term upside potential, investors should carefully assess the company's operational execution and market dynamics. Monitoring developments and regulatory statuses will be crucial in gauging momentum in this burgeoning sector. With strategic partnerships and innovative solutions, CBSC is certainly one to watch in the health tech space.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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 $375,000 USD. Delivery of the first 1,000 devices will occur upon completion of production (currently underway), with the balance scheduled for shipment within 90–120 days.
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
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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**
How does CB Scientific Inc CBSC plan to leverage its recent Medical Device License approval in Canada to increase market penetration and revenue through its CardioHolter AT device?
What strategic partnerships does CB Scientific Inc CBSC have in place to optimize the distribution and support of its CardioHolter AT device in the Canadian market?
Can CB Scientific Inc CBSC provide insights into the expected financial performance from the initial order placed by Your Heart Protector Corp. and the anticipated impact on overall company growth?
What measures is CB Scientific Inc CBSC implementing to ensure the success of its monthly rental program for the CardioHolter AT in Canadian healthcare facilities?
**MWN-AI FAQ is based on asking OpenAI questions about CB Scientific Inc (OTC: CBSC).
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