Forsante Ltd has been granted an EU Medical Devices MDR certification by SGS. Obtaining the certification requires the medical device to meet strict patient safety and system requirements. The IRMA AI module from Forsante is now CE-marked in the demanding Class 2b risk category and, to our knowledge, is the first clinical decision support solution in Europe to receive this designation.
IRMA is a logic-based decision support module that utilizes rule sets derived from clinical guidelines, enabling clinical automation. Accurately following these often complex rule sets is challenging due to the limitations of human cognitive capacity. IRMA interprets clinical guidelines and medical data in a manner similar to a physician, adapting to diverse and complex patient needs.
With IRMA, it is possible to reliably generate diagnoses and recommendations for monitoring and treating various diseases in accordance with clinical guidelines. Every recommendation made by IRMA includes logical justifications, ensuring that healthcare professionals can always review the suggestions. IRMA can also provide personalized medication recommendations tailored to individual patients.
Currently, the IRMA module is used at Forsante for monitoring and dosing the antipsychotic medication clozapine, and it can be integrated into other information systems, such as electronic health record (EHR) systems. Thanks to its rule-based structure, new medical guidelines and protocols can be quickly implemented in IRMA, keeping the system up to date and compliant in the rapidly evolving healthcare environment. In the future, Forsante plans to utilize the IRMA AI module to support decision-making in the treatment of diabetes and other major public health diseases.
