Sonio Diagnostics CE

Sonio Diagnostics becomes CE marked!

On May 26, 2021, Sonio Diagnostics, Sonio’s first product, was marked CE Class 1 medical device according to directive 93/42/EEC. Based on Artificial Intelligence and an expert database, this medical device guides practitioners through the fetal ultrasound and helps them to make a diagnosis.

The result of research in both mathematics and fetal medicine

After more than five years of research and collaboration between mathematicians from the École Polytechnique and prenatal diagnosis experts from the Hospital Necker Enfants Malades, Sonio has launched its first product on the market. Sonio Diagnostics is a SaaS software that supports the practitioner in monitoring pregnancy. The underlying algorithm analyzes data relating to the patient’s medical history, risk factors and signs observed during the ultrasound. It guides the practitioner to look for ultrasound signs most likely associated with a risk factor or a first anomaly seen during the ultrasound. Sonio then proposes a list of probable diagnoses based on an expert database aggregating nearly 300 prenatal syndromes and over 700 ultrasound signs. Sonio Diagnostics can be used by practitioners to prepare a consultation, in real time during the examination, or afterwards to deepen their diagnostic path.

Clinical validation

Sonio Diagnostics has been clinically validated, achieving a diagnostic performance rate of more than 97% when the full phenotype is provided (diagnosis confirmed by fetopathology present in the top 7 diagnoses proposed by Sonio). The scientific article resulting from the clinical validation is available at the following address: https://doi.org/10.1101/2021.05.25.21257630.

Benefits after CE marking

By guiding the examination and optimizing diagnostic performance, Sonio Diagnostics aims to reassure both the practitioner and the pregnant woman. This companion tool aims to increase the quality of the ultrasound examination and is an element of continuing education in fetal medicine. It structures information, facilitates the sharing of medical records between colleagues, and encourages interaction between doctors. Sonio Diagnostics can be used in particular by doctors in CPDPNs (Multidisciplinary Centres for Prenatal Diagnosis), the leading expert centres for prenatal diagnosis in France, in the preparation and organization of multidisciplinary staff meetings.

Protection of patient data

The protection of personal and health data is a priority for Sonio. That is why Sonio Diagnostics complies with the standards for medical data and the quality of a medical device (ISO 13485: 2016). The data is stored at a certified health data hosting company.

The team that made this possible

In just one year, Sonio has built a team of over twenty people with expertise in prenatal diagnostics, tech, mathematics, Artificial Intelligence, product, regulatory and business development. The team is continuously developing a suite of products to improve the health of pregnant women.

“We’ve come a long way in the last year. We could never have achieved this goal without an extremely committed team and a community of testers who are incredibly motivated to help us develop this product. I want to thank them today and wish us all the same level of energy and success for the future. This is just the first step in our project to support the medical community in improving the pathway and quality of care for women.”

Cécile Brosset, CEO and co-founder Sonio

“Sonio Diagnostics relies on a large database of various types of data, including ultrasound (phenotypic), genetic and biological data, and offers to follow an optimized protocol until diagnosis. For the practitioner, using Sonio Diagnostics is like having a second expert opinion in real time, using a navigation system that knows how to manage the almost infinite number of possible combinations of anomalies. Bringing diagnostic value to fetal ultrasound is a real innovation, both technological and medical”

Rémi Besson, Chief Scientific Officer et co-founder Sonio.

Thanks to the CE mark, Sonio will start marketing its product to diagnosticians in France and Europe by the end of 2021.