January 15, 2026
Information presented above is based on publicly disclosed Company announcements. Investors are encouraged to review all press releases and filings in their entirety.
This timeline summarizes key regulatory, product, and commercialization milestones disclosed by Cardiac Biotech Solutions, Inc. Investors are encouraged to review the linked press releases for full details.
U.S. FDA Clearance – MyCardia AT
The Company announced that its MyCardia AT ambulatory cardiac event monitoring device received clearance from the U.S. Food and Drug Administration, enabling commercial distribution in the United States.
Health Canada Medical Device License (MDL) Issued
Health Canada issued a Medical Device License (MDL) for MyCardia AT, marketed in Canada as CardioHolter AT, permitting importation and commercialization in Canada.
Initial Canadian Commercial Launch & Distributor Engagement
The Company announced Canadian commercialization activities through its licensed distributor following receipt of the Health Canada MDL.
Initial International Purchase Order – Central America
The Company announced an initial purchase order for 2,500 MyCardia AT devices from its Central America partner, Noventis Medical, with an associated commercial rollout.
Recurring Revenue Program Announced
The Company disclosed the launch of a recurring revenue model, including device rental and monitoring services integrated with its cloud-based platform and mobile applications.
China Regulatory & Market Preparation
The Company disclosed that it resumed and continues regulatory and commercialization preparations in China in collaboration with manufacturing and distribution partners. Regulatory review is subject to the National Medical Products Administration (NMPA) and applicable local requirements.
Ongoing & Future Updates
The Company expects to provide updates as additional regulatory, manufacturing, shipment, or commercial milestones occur. Timing and outcomes are subject to regulatory review, partner execution, and operational factors.
Important Notice
This timeline is for informational purposes only and is based on publicly disclosed Company announcements. It does not constitute investment advice or an offer to buy or sell securities.
Cardiac Biotech Solutions, Inc. develops and commercializes non-invasive ambulatory cardiac monitoring devices, supported by cloud-based software and mobile applications. The Company’s technology is designed to assist physicians in the detection and evaluation of cardiac arrhythmias during extended monitoring periods.
MyCardia AT is the Company’s ambulatory cardiac event monitoring device designed for extended patient use. The system integrates a lightweight wearable monitor with cloud connectivity and mobile applications that support data transmission and physician review.
The Company has disclosed that MyCardia AT has received clearance from the U.S. Food and Drug Administration, enabling commercial distribution of the device in the United States, subject to applicable regulatory and compliance requirements.
Investors should refer to the Company’s press releases for details regarding the scope of clearance.
The Company has disclosed that Health Canada issued a Medical Device License (MDL) for MyCardia AT, marketed in Canada as CardioHolter AT. The MDL permits importation and commercialization of the device in Canada in accordance with Canadian regulatory requirements.
The Company has announced distributor agreements and initial purchase orders in Canada and international markets. Revenue recognition depends on production, shipment, deployment, and usage of devices under commercial arrangements, as disclosed in Company press releases.
The Company does not provide forward-looking revenue projections.
The Company has disclosed a commercialization approach that may include device sales or placements through distributor partners and recurring revenue programs, including monthly rental and monitoring arrangements that incorporate device usage, cloud software, and mobile applications.
Commercial terms vary by jurisdiction and partner and are disclosed as appropriate through Company announcements.
The Company has disclosed that it is advancing regulatory and distribution initiatives in international markets, including China, in collaboration with manufacturing and distribution partners.
Regulatory progress in China is subject to review by the National Medical Products Administration (NMPA) and applicable local requirements. No assurances can be made regarding timing or outcome.
The Company has disclosed that it may evaluate strategic opportunities as part of its ongoing business development activities. As of the most recent public disclosures, no binding agreements relating to mergers, acquisitions, or corporate transactions have been announced unless specifically stated in Company press releases.
The Company communicates material developments through official press releases and updates posted on its website. Investors are encouraged to review all Company announcements in their entirety.
Official Company information is available on the Company’s website under the Investors section, including press releases, regulatory updates, and contact information.
For investor inquiries:
📧 investor@cardiacbiotech.com
Important Notice
This FAQ is provided for informational purposes only and is based on publicly disclosed Company information. It does not constitute investment advice or an offer to buy or sell securities. Investors should rely on official Company disclosures and filings when making investment decisions.
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