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Scanvio Medical, a Zurich-based company, has received CE marking for Scanvio Assist as Class IIa medical device software under the EU Medical Device Regulation (EU MDR 2017/745), following conformity assessment by notified body TÜV SÜD (NB2443). The assessment covered the company’s quality management system and the technical documentation for the software. To the company’s knowledge, Scanvio Assist is the world’s first CE-marked AI-assisted ultrasound technology developed to help clinicians identify signs of endometriosis.
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The need is large. The World Health Organization estimates endometriosis affects about 10% of women of reproductive age, around 190 million people. Ultrasound can reveal signs of the condition, but the quality of the examination depends heavily on the examiner’s expertise, and access to timely diagnosis remains limited. Scanvio Assist runs alongside existing ultrasound equipment and provides real-time AI support during the exam, with the aim of making high-quality endometriosis ultrasound available in a wider range of clinical settings.
With certification in place, the company is onboarding its first gynecologists, fertility clinics, and endometriosis centers across Europe and inviting additional institutions to become early users. CEO and co-founder Dr. Stefan Tuchschmid said the milestone is exciting, but “what excites us most is what comes next”: bringing the software into real clinical practice.
For the broader MedTech space, the certification adds to the growing set of AI tools that aim to extend specialist skills into routine imaging, here in women’s health, an area where diagnostic delay is a persistent problem.
