Zurich, Switzerland, October 9, 2026 – Scanvio Medical today announced that Scanvio Assist™ has received CE marking as a Class IIa medical device software under the European Medical Device Regulation (EU MDR 2017/745), following conformity assessment by TÜV SÜD NB2443.
The certification enables Scanvio Medical to begin bringing Scanvio Assist™ into clinical use across Europe. To the company’s knowledge, Scanvio Assist™ is the world’s first CE-marked AI-assisted ultrasound technology specifically developed to support clinicians in identifying signs of endometriosis.
Endometriosis affects an estimated 10% of women of reproductive age worldwide – around 190 million people, according to the World Health Organization. Yet access to timely diagnosis and specialized care remains limited. Ultrasound can play an important role in identifying signs of endometriosis, but examination quality depends heavily on clinical expertise.
Scanvio Assist™ works with existing ultrasound equipment and provides real-time AI-assisted support during the examination, with the goal of making high-quality endometriosis ultrasound more accessible across a broader range of clinical settings.
“Receiving CE marking is a major milestone, but what excites us most is what comes next: bringing Scanvio Assist into real clinical practice,” said Dr. Stefan Tuchschmid, CEO and Co-founder of Scanvio Medical. “We have spent the past years developing and validating this technology together with clinicians, and I’m incredibly proud of the great work our team has done. Now we can put it into the hands of gynecologists and sonographers and start seeing its impact in everyday care. Our ambition is to make high-quality endometriosis ultrasound more accessible, and we are incredibly excited to take this next step together with our first clinical users.”
With CE marking now in place, Scanvio Medical will be onboarding its first gynecologists, fertility clinics, and endometriosis centers across Europe. The company is beginning its first clinical rollouts and is inviting additional healthcare professionals and institutions interested in becoming early users of Scanvio Assist™ to get in touch.
The CE marking follows the successful completion of Scanvio Medical’s conformity assessment under the EU MDR with TÜV SÜD NB2443, including the assessment of the company’s quality management system and technical documentation for Scanvio Assist™.
Gynecologists, fertility clinics, and endometriosis centers interested in using Scanvio Assist™ can register their interest at [email protected].
Scanvio Medical AG is an ETH Zurich spin-off developing AI-assisted ultrasound technology to support clinicians in identifying signs of endometriosis. Its flagship product, Scanvio Assist™, provides real-time AI support during transvaginal ultrasound and is designed to integrate into the existing clinical workflow.
Scanvio Medical is headquartered in Zurich, Switzerland, and works with clinical and research partners globally.
