Cardiac Biotech Solutions, Inc. (OTCID: CBSC) is a medical device company focused on non-invasive ambulatory cardiac monitoring, supported by cloud-based software and mobile applications.

The Company’s flagship product, MyCardia AT, is designed to assist physicians in the detection and evaluation of cardiac arrhythmias during extended monitoring periods.

Key Regulatory & Commercial Milestones

  • United States: The Company has received clearance from the U.S. Food and Drug Administration for its MyCardia AT cardiac event monitoring device, enabling commercial distribution in the U.S.
  • Canada: The Company has received a Medical Device License (MDL) from Health Canada for MyCardia AT (marketed in Canada as CardioHolter AT), permitting import and commercialization.
  • Commercialization: The Company has announced initial distributor purchase orders and commercial agreements in Canada and international markets.
  • International Expansion: The Company is advancing regulatory and distribution initiatives in additional international markets, including China, in collaboration with manufacturing and distribution partners.
Key Achievements

FDA-cleared

FDA-cleared MyCardia AT device (United States)

Health Canada

Health Canada Medical Device License (MDL) issued

Initial Distributor

Initial distributor purchase orders announced

Recurring revenue

Recurring revenue program launched

International regulatory

International regulatory expansion underway

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