We are proud to announce that our flagship device, Fetoly-Heart, has received CE marking and ISO13485 certification, confirming its compliance with European regulatory standards!

The first-ever real-time software solution ensuring the completeness of fetal cardiac ultrasound examinations. Running locally without any cloud dependency, it analyzes every frame of your live ultrasound stream in real time, eliminating the need to manually freeze images—the software does it for you!

Our device is clinically validated to detect fetal cardiac views and identify over 50 anatomical heart landmarks associated with the majority of fetal cardiac malformations. It is designed to work from 17 weeks of gestation across major ultrasound OEMs, even in challenging cases such as poor image quality and pathological fetal development.

🚀 A major step forward in improving prenatal cardiac screening in Europe!