“We develop and deliver medical devices. Our software – powered by artificial intelligence, is designed to be safe, effective, and secure for our customers and patients. We care deeply about protecting health information.”
Head of RAQA and Privacy Compliance Officer at Sonio
Sonio and Global Medical Device Regulations
United States of America
- Sonio Detect is US FDA 510(k) cleared. Sonio Detect is intended to analyze fetal ultrasound images and clips using machine learning techniques to automatically detect views, detect anatomical structures within the views and verify quality criteria of the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. The 510(k) summary is publicly available here in FDA’s database.
- Sonio Pro is US class I medical device and a “medical image communication device”. Sonio Pro is intended to help Healthcare Practitioners to make sure US screening exams are well performed.
European Union (EU)
- Sonio Detect is class IIa medical device according to the EU medical device regulation 2017/745. Sonio Detect CE mark certification is ongoing.
- Sonio Pro is not a medical device in EU. Sonio Pro is intended to help Healthcare Practitioners to make sure ultrasound screening exams are well performed.