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Cardiac Biotech Solutions, Inc. Secures Health Canada License for MyCardia AT Device, Now Branded as CardioHolter AT
Cardiac Biotech Solutions, Inc. Secures Health Canada License for MyCardia AT Device, Now Branded as CardioHolter AT.
About this update from Cardiac Biotech Solutions Inc.
[{"type":"text","content":"\r\n\r\n \r\n \r\n Cardiac Biotech Solutions, Inc. Secures Health Canada License for MyCardia AT Device, Now Branded as CardioHolter AT\r\n \r\n \r\n\r\n\r\nCardiac Biotech Solutions, Inc. Secures Health Canada License for MyCardia AT Device, Now Branded as CardioHolter AT\r\n\r\n\r\n\r\n\r\n\r\nLAS 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 ...