Scanvio Assist, software developed by Scanvio Medical, has received CE marking as Class IIa medical device software under the European Medical Device Regulation. The information comes from a press release published on 9 October 2026 by Startupticker.ch. According to the release, the certification allows the company to begin introducing the tool into clinical practice in Europe. The headline of the publication presents it as the “world’s first CE mark” for AI-assisted ultrasound in endometriosis: this is a claim made by the company, which the source does not substantiate further.

The starting problem: an examination that depends on expertise

The release points out that endometriosis affects around 10% of women of reproductive age worldwide, or some 190 million people, according to the World Health Organization. Yet access to rapid diagnosis and specialised care remains limited, it adds.

Ultrasound can play an important role in detecting signs of the disease, but the quality of the examination depends heavily on the clinical expertise of the person performing it. This is where Scanvio Medical positions its software.

What the tool does, according to the company

Scanvio Assist works with existing ultrasound devices. It provides healthcare professionals with real-time, AI-assisted support during transvaginal ultrasound. The stated aim is to make high-quality endometriosis ultrasound accessible in a wider range of clinical settings.

The source does not detail how the tool works technically: it specifies neither the exact nature of the assistance displayed during the examination nor the data on which the system was trained. Nor does it provide any quantified results on its performance.

What the CE marking says, and what it does not

According to the release, the CE marking follows the completion of Scanvio Medical’s conformity assessment under the European Medical Device Regulation (EU MDR 2017/745), carried out with the notified body TÜV SÜD (NB2443). This assessment covered the company’s quality management system and the technical documentation for Scanvio Assist.

What is established, therefore, is the outcome of this conformity procedure and the classification of the software as Class IIa. The source does not specify what clinical evidence was provided in this context, nor whether validation studies have been published. The company states that it developed and validated the technology with clinicians, without the release describing this work. The tool’s effect on diagnostic delays or on patient care remains, at this stage, a prospect rather than a demonstrated result.

The announced next steps

“Obtaining CE marking is a major milestone, but what excites us most is what comes next: bringing Scanvio Assist into real-world clinical practice,” says Dr Stefan Tuchschmid, CEO and co-founder of Scanvio Medical, quoted in the release. “We have spent the past few years developing and validating this technology with clinicians,” he adds, before expressing the wish to “start seeing its impact in everyday care”.

In concrete terms, Scanvio Medical announces that it will onboard its first gynaecologists, fertility clinics and specialised endometriosis centres in Europe. The release does not name any of these first users and gives no timeline. The company is also targeting ultrasound device manufacturers, which could integrate Scanvio Assist as an add-on software module into their existing platforms. No partnership of this kind is mentioned at this stage.

And Switzerland?

The information was published by Startupticker.ch. However, the release specifies neither Scanvio Medical’s headquarters nor any links with Swiss institutions or clinics. Nor does it mention any planned deployment in Switzerland: it refers to Europe in general.

Sources