French firm Sonio has received FDA 510(k) clearance for an AI-powered way to monitor foetal ultrasound examinations in real time.

Called Sonio Detect, it is a software-as-a-service (SaaS) offering that helps sonographers, obstetrician-gynaecologists, maternal-foetal medicine specialists and foetal surgeons perform their routine ultrasound examinations.

Sonio Detect leverages deep learning networks to assist ultrasound practitioners in ensuring better quality, efficiency and expertise throughout the entire exam in real time by automatically detecting and labelling views, detecting anatomical structures within supported views, and verifying quality criteria of the supported views by checking whether they conform to standard criteria.

It can integrate with various ultrasound manufacturers, and is verified to have high sensitivity and specificity and maintain high accuracy across various subgroups of patients, including BMI, maternal age and ethnicity.

“The FDA’s recognition is a result of our team’s hard work and determination,” said Cécile Brosset, CEO of Sonio. “I want to express my gratitude to Florian Akpakpa, our head of regulatory affairs, for leading this effort till the end, and to the entire team for their incredible dedication. This accomplishment also reaffirms our commitment to give access to high-quality prenatal care to people all around the world.”

Rémi Besson, chief scientific officer at Sonio, added: “This milestone marks just the beginning of an exciting journey. Sonio Detect’s FDA clearance propels us into a future where technology and medicine converge to reshape healthcare. The possibilities are limitless, and this achievement reinforces our dedication to the path ahead.”

The AI-augmented ultrasounds offer a window into the health and development of foetuses. This technology-driven experience can provide a deeper connection and understanding, alleviating anxieties and offering a clearer picture of the journey ahead. See sonio.ai for more information.