Announcement • Sep 26
Cardiac Biotech Solutions, Inc. Secures Health Canada License for MyCardia AT Device, Now Branded as CardioHolter AT Cardiac Biotech Solutions Inc. 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. 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. 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 cardiac monitoring solutions worldwide. Announcement • Oct 03
CB Scientific, Inc. Announces Chief Financial Officer Changes CB Scientific, Inc. announced that the Company's Board of Directors appointed Mr. William "Trip" Thomas as its Chief Financial Officer effective October 1, 2024. Mr. Thomas is replacing Ms. Brooke Turk who formally tendered her resignation effective September 30, 2024. Ms. Turk's resignation was not the result of any disagreement or conflict with the Company. Mr. Thomas earned a Bachelor of Science degree in Accounting from the University of Tampa and holds a Bachelor of Science degree in Agribusiness from the University of Florida. He is a licensed Certified Public Account in the State of Florida. Announcement • Sep 07
CB Scientific, Inc. Announces FDA 510(k) Submission of Enhanced myCam Cardiac Event Monitor CB Scientific, Inc. announced that it has completed the regulatory testing phase of its latest myCam cardiac event monitor design and has formally tendered a 510(k) submission for Clearance to Market to the U.S. Food and Drug Administration (FDA). The company anticipates a response from the FDA for this 510(k) submission in approximately 90 to 120 days. During the review process, CBSC looks forward to collaborating with the FDA in a concerted effort to obtain Clearance to Market for the new myCam product as quickly as possible. Upon receiving FDA clearance, the company intends to market the device domestically, as well as internationally throughout Asia, Latin America, India and the Middle East, each of which require FDA certification. 
