News

New TEF-Health newsletter up on LinkedIn

Get the latest on upcoming events and success stories from SMEs using TEF-Health services. In this issue: 

- Launching the TEF-Health Hospital Network Pitch Sessions  – 10 European Hospitals listening to SMEs ideas, needs and challenges.

– The story of Cortex Machina, a neurology-focused start-up that quickly overcame a key hurdle on its path to market supported by TEF-Health – and more.

TEF-Health highlighted in Nature Medicine

In a recent article published in Nature Medicine, TEF-Health is recognised as one of the Nordic region’s key AI assets, alongside the Centre for AI Innovation at Karolinska Institutet, which leads the Swedish TEF-Health node.

New TEF-Health newsletter up on LinkedIn

Get the latest on upcoming events and success stories from SMEs using TEF-Health services.

Meet us in Berlin June 9 – Transforming Healthcare with Trusted AI, Robotics and Data

On 9 June 2026, TEF-Health hosts an international summit in Berlin bringing together startups, SMEs, healthcare providers, policymakers, and investors to explore how European infrastructures are enabling the testing, validation, and deployment of trustworthy AI and robotics in healthcare. 

EU agrees clearer path for Health AI

Although healthcare AI developers face 1–2 more years of uncertainty as the EU revisits the AI Act, one major change could simplify life for medical‑device startups and SMEs.

The European Union is conducting a large-scale review of digital regulation, announced in 2025, which aims to simplify and streamline regulation for business and individuals alike, and boosting competitiveness and lowering ultimate cost.

Medical AI moves from AI Act into MDR

One of the most anticipated changes is the way that medical AI devices will be assessed. If the rules enter into force, Medical Device AI will no longer be assessed as part of the AI Act, but directly as part of the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR) conformity assessment procedures.

Guidance and support for SMEs

For SMEs, the biggest challenge now is uncertainty – timelines are shifting, requirements are changing, and enforcement in part is delayed. In this context, there is a growing need for practical guidance, testing, and validation support to bridge the gap between high-level regulation and real-world implementation. TEF-Health, as an EU-wide initiative and recognised implementation support instrument under the AI Act, is addressing this need by providing guidance to SMEs and staying updated on the latest changes.

Welcome to a webinar on TEF-Health Digital & Virtual Evaluation Environments on March 3. 

This session will introduce CHU de Rennes and CHU Grenoble Alpes virtual testing infrastructures and digital validation services supporting SMEs in preparing AI-driven medical technologies for regulatory compliance and market readiness.

You will gain insights into:

• AI model validation & performance testing
• Data-based evidence generation
• Regulatory preparation before clinical deployment

Read the November edition of the TEF-Health newsletter –  your monthly dose of AI innovation, insight and impact.

Around 200 AI enthusiasts – from SMEs, healthcare providers, academia, decision-makers, and service providers for AI development – gathered last week at KI to discuss different aspects of implementing AI in healthcare.

Building trustworthy AI in healthcare: collaborative efforts for Europe

How to deploy trustworthy AI in healthcare was the topic of the day when clinicians, innovators, representatives from industry and academia met with decision-makers and funders at an event highlighting real-world experiences of AI development and implementation in healthcare. The event also showcased new models of co-creation between healthcare providers and industry, to lay the foundation for more ethical, effective, and collaborative AI innovation across Europe.

Event 16 October 2025: Deploying Trustworthy AI in Healthcare – Validation and Adoption

Welcome to an afternoon focused on how to develop, validate, and adopt AI in healthcare. This gathering will bring together healthcare providers, companies, policymakers, and service providers promoting AI development.

Major EU funding for development of AI in healthcare

Researchers at Karolinska Institutet, the Centre for Imaging Research (CIR), SciLifeLab, and RISE have together received a grant of over SEK 100 million from the European Commission's Digital Europe programme. The project, called TEF-Health, will, among other things, promote the rapid introduction of new artificial intelligence (AI) and robotics solutions in healthcare.

TEF-Health Sweden node-coordinator Johanna Furuhjelm presents the European Testing and Experimentation Facility for Health AI and Robotics at Vitalis 2024.