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Clear.bio earns CE mark and launches smart innovations in digital diabetes care to enable European expansion

Health Tech start-up Clear.bio is launching two new features that redefine how digital lifestyle interventions support people with (pre)diabetes: Smart Swap and Smart Signal. These innovations deliver real-time, personalized advice at scale – based on each user’s individual glucose data. The launch coincides with a major milestone: Clear.bio is now officially registered as a Class I medical device under European MDR regulation. This certification confirms compliance with the highest medical standards in Europe and opens the door for international expansion – starting with France and Germany.

 

From manual work to scalable personalisation

The new features showcase the true potential of a digital solution that is both personalised and medically validated. Previously, dietary advice was provided manually by dietitians. Now, the app offers tailored guidance automatically, using each user’s glucose data and personal profile.

Smart Swap provides actionable tips such as: “Swap mashed potatoes for mashed celeriac in this meal,” or “This fruit portion contains 25 grams of carbohydrates – try to stay under 15 grams.”
Meanwhile, Smart Signal sends real-time alerts when unusual glucose fluctuations occur: “Your blood sugar is rising quickly – consider going for a walk,” or “Caution: possible hypo.”

“This marks a shift from manual work to scalable personalisation,” says Clear.bio founder Piet Hein van Dam. “Our app anticipates user needs and responds at just the right moment – without always needing a healthcare professional. That’s how we make digital diabetes care accessible to far more people, without compromising on quality.”

The role of the dietitian remains essential, Van Dam emphasises. “They’re still there for complex situations and personal guidance – like answering questions in the app – but now they’re supported by smart technology that works around the clock.”

 

Medical validation as a launchpad for European growth

The MDR certification is not an end in itself, but a crucial step for scaling. It proves that Clear.bio’s intelligent features meet European standards for safety, effectiveness and data protection.

“This milestone clears the way to scale diabetes care across Europe,” says Van Dam. “Health systems across the continent are under pressure – and we know that lifestyle plays a key role in chronic disease. By validating our technology medically, we can offer broader, more affordable support to millions of people with diabetes.”

 

Expansion begins in France and Germany

The rollout starts in France and Germany – two countries facing rising healthcare pressure and growing numbers of people with type 2 diabetes. In Germany alone, projections estimate that more than 10 million people will have diabetes by 2040.

There is a growing demand in both countries for innovative solutions that support lifestyle change and are integrated into routine care.

“The future of healthcare is preventive and personalised – but it must also be scalable, reliable and evidence-based,” Van Dam continues. “We’re building a platform that makes diabetes care a fully integrated and medically sound part of the European healthcare system.”

 

See the future of digital care at HLTH Europe

These developments are being showcased today at HLTH Europe in Amsterdam (June 16, 2025). Clear.bio is participating as an alumnus of Google for Startups’ AI for Health program and will be present at stand A30-3.

Visit our stand to meet CEO Piet Hein van Dam and Chief Scientific Officer Madelon Bracke, and learn how smart technology, medical validation and behaviour change come together in one powerful approach.

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