IntelligynAI – Regulatory support setting up a QMS and technical files for MDR

Purpose and goal: IntelligynAI is an AI-driven decision support, intended for use in the ultrasound diagnosis of

ovarian tumors that helps the examiner distinguish between benign and malignant tumors. IntelligynAI a medical device class IIB. We are currently running the regulatory/clinical studies at Södersjukhuset which will be completed in Q4 2024. The purpose of this proposal is to take Intelligyn the last step towards a fully developed quality management system and technical documentation

so that we can submit to our notifying body BSI within 1-year. Expected results and effects: The AI models included in the IntelligynAI platform have a scientifically proven diagnostic accuracy that equals or exceeds ultrasound experts, with a

robust performance across different patient populations, ultrasound systems and tumor types. We have also shown that introducing AI-driven support as a ´second reader´ can reduce resource utilization by 63% while simultaneously increasing diagnostic precision. We believe that this leads to better resource utilization, reduced queues, fewer unnecessary operations and delayed cancer diagnoses.

Approach and implementation:

We have already started work on developing a QMS system for Intelligyn. We were recently approved by the Swedish Medicines Agency to start our clinical regulatory studies IntelligynAI-FS, CIV ID: CIV-24-02-046166 (Dnr 5.1-2024-28221). In parallel with the regulatory studies continuing, we will compile the technical documentation required to be able to send the documents to our NB BSI.