Sonio receives CE mark for its AI-powered Sonio Detect, expanding its ultrasound reporting solutions in France, after FDA clearance and US market success.
Sonio, the medtech company specializing in women's and children's health, announced today that it has received CE marking for its product Sonio Detect . Sonio Detect, the software for automatic detection of views, anatomical structures and quality criteria on ultrasound images already marketed by Sonio in the United States, is now available in France.
Founded in 2020 to improve the health of women and children worldwide through medical advances, Sonio specializes in women's and children's health and develops AI solutions for obstetric and gynecological ultrasound. In July 2023, Sonio marked a significant milestone by receiving FDA 510(k) regulatory clearance for its Sonio Detect product. In February 2024, the company reached a new milestone by signing its first U.S. customer, Pediatrix Medical Group, Inc. the leading specialist care provider for women, children and infants in the U.S., enabling Sonio's ultrasound reporting solution to be deployed in over 100 clinics across the country over the course of two years. With the CE mark obtained for its Detect product, Sonio intends to expand its business in Europe, particularly in France. Now backed by Samsung Medison, the company will be stepping up its expansion and continuing to build its reputation.
Sonio Detect is designed to guarantee high-quality examinations, automatically detecting views, anatomical structures and checking predefined quality criteria of ultrasound images. Sonio's cloud software ensures continuous updates to incorporate the latest advances in imaging technology, AI algorithms and clinical decision support systems. With powerful automation tools, customizable protocols, reporting templates based on ultrasound examination results and decision support functionalities, Sonio aims to improve screening accuracy. Sonio aims to fill gaps in the detection of structures, views and anomalies to refine screening and diagnosis, and thus significantly improve the care of women and children.
