Legal Alert: Advising an AI-Powered Software as a Medical Device Developer on Clinical Investigation Agreements and Grant-Funded Innovation
Publication date: May 11, 2026
We recently advised a Polish medtech company developing an innovative artificial intelligence-powered Software as a Medical Device (SaMD) designed to support early detection of cardiovascular disease based on standard electrocardiogram (ECG) recordings.
The client is developing software that performs automated analysis of resting ECG data and generates additional diagnostic insights for physicians. While the patient experience remains identical to a standard ECG examination, the software applies advanced signal processing and AI-driven analytics to extract significantly more information from the underlying electrical activity of the heart. The current version is intended for use in clinical settings, while a next-generation solution is being developed for home use, enabling remote screening and telemedicine-based monitoring.
