With the grant funding, the OMI AI ECG Model has been further developed, demonstrating significantly improved sensitivity while maintaining a fixed specificity of 98%. The model also shows strong performance across various subgroups, including signal variations, different diagnoses, and morphological differences. It has been successfully integrated into the PMcardio for Organizations platform. An API interoperability module has been developed, enabling the PMcardio for Organizations platform to integrate seamlessly with other devices
A foundation for robust clinical evidence supporting the model’s safety and efficacy has been established with the submission of a prospective observational study protocol, and the first patients have already been enrolled.
To protect the intellectual property of the OMI AI ECG model, an IP management plan has been developed, and a trademark application for “Queen of Hearts” has been submitted.
To communicate the benefits of the OMI AI ECG Model and its impact on patient outcomes, as well as to share preliminary project results, communication activities have been conducted according to the dissemination and communication plan. A risk management plan was also implemented to mitigate potential risks, and, to date, none have materialized. Additionally, a data management plan has been created and regularly updated to ensure secure data handling throughout the project lifecycle.
An Ethics Advisor was appointed at the start of the project, and their initial report confirms that the ethical framework and measures taken by Powerful Medical are satisfactory.
As outlined in Section 2 of D5.3 First interim implementation report, all deliverables due in the first reporting period (January 1, 2024, to October 31, 2024) have been successfully completed. For further details, please refer to the respective reports.
The investment component will be accessed later on to further help cover costs for mass commercialisation and adoption of the solution - mainly engaging key opinion leaders, validating strategies for reimbursement, participating in conferences and exhibitions, and post-market surveillance. It will also cover the long-term RCTs necessary for guideline implementation.
