ZNEXT invests €150,000 in Ardeevo, the startup using AI to unlock medical technologies awaiting CE marking

Milan, 5 October 2026 — No medical or diagnostic device can be sold in Europe without CE marking. From pulse oximeters to diagnostic software, more than 106,000 product families must now go through this process, yet only 71 bodies in total are authorised to carry it out, with ever smaller staff. On one side, people who need more effective diagnosis and care have to wait longer; on the other, the companies that develop them, 90% of which are startups and SMEs, rarely have an in-house regulatory team able to manage the documentation required. Ardeevo was founded to offer them exactly this expertise.

The Rome-based startup, co-founded with ZNEXT, brings together the legal and technological expertise of its two founders: Giovanni Stracquadaneo, legal expert, lecturer in healthcare innovation and serial entrepreneur, and Alessandro Santopaolo, expert in artificial intelligence applied to healthcare and robotics.

Less hourly consulting, more results at a fixed price

Ardeevo supports companies along the entire regulatory path of their devices, from the qualification and classification of the product to the delivery of the technical file. The entry point is Clark, the platform’s regulatory assistant, which gathers the information through a guided interview and indicates the next steps at each stage.

Based on this data, a system of artificial intelligence agents consults a knowledge base of hundreds of regulatory documents, drafts the sections of the technical file, links each statement to the regulatory reference it derives from and checks the overall consistency of the dossier. No document is released without the mandatory review of an expert.

It is precisely this combination that sets Ardeevo apart. According to a mapping of 70 operators in the sector carried out by the startup, none today combines, in a single natively AI-based platform, the consistency check of the whole technical file, the selection of the notified body best suited to the individual device and systematic review by regulatory experts.

The business model reverses that of consulting: a fixed price per risk class, defined delivery times and payments tied to progress milestones. As European regulation requires, the technical documentation remains the responsibility of the manufacturer and the conformity assessment is the task of the notified body. Ardeevo works upstream, in the phase where most delays and costs are concentrated today.

“Today regulatory affairs are experienced as an obstacle to face at the end of a project, when the product is already built and every correction costs time and money. We want to bring them to the start of the path and turn them into an advantage, because those who know the rules from day one design better and reach the market sooner,” explains Giovanni Stracquadaneo, co-founder and CEO of Ardeevo. “In other words, Ardeevo gives startups and SMEs the same regulatory expertise that large companies can count on, without the weight of an in-house structure.”

The fifth venture in ZNEXT’s portfolio

As with every startup of its venture building, ZNEXT works alongside Ardeevo as co-founder, with a pre-seed investment of €150,000, continuous operational support and access to the expertise and network of the Zanichelli Group. Ardeevo thus becomes the fifth company of the industrial platform born on Zanichelli’s initiative, after Ekory, Pausetiv and Zetamed, launched within the venture building, and Factanza Media, in which ZNEXT acquired a majority stake last April.

The choice looks to a large market. The European medical and diagnostic technology market is worth about €170 billion, 26.4% of the world total, second only to the United States. According to Ardeevo’s market estimates, spending on compliance with the MDR and IVDR regulations will reach about €22 billion by 2033.

“Bringing artificial intelligence into a regulated sector such as medical devices means changing the way thousands of companies work, starting with SMEs and startups. They are the ones that today feel most the imbalance of a sector in which requests for certification grow while the capacity to review them shrinks,” says Elena Lavezzi, CEO of ZNEXT. “Ardeevo is exactly the kind of company we want to build. Giovanni and Alessandro have complementary skills, know the problem from the inside and have identified a market served only in part so far. Our role is to give this insight the industrial solidity to become a company.”