September 11, 2024

News

FDA clearance

Major Milestone for Diagnoly

We are proud to announce that our flagship device, Fetoly-Heart, has been FDA cleared this week.

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, without any need to manually freeze images – the software does it for you!

Our device is proven efficient in detecting fetal cardiac views and in identifying and localizing over 50 anatomical heart landmarks associated with the majority of fetal cardiac malformations. It is developed to work from 17 weeks of gestation across major OEMs, with a focus on challenging cases such as poor image quality and pathological fetal development.

It will be showcased at the upcoming ISUOG Congress. Stay tuned for further developments.

For a free trial, please contact us at sales@diagnoly.com