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Clinical Evidence Requirements For AI Must Be Based On Purpose, EU Expert Group Says

 
• By Eliza Slawther

EU guidance on clinical evidence requirements for medical device software does not yet include AI-specific information. An expert group explains how regulators can determine how much evidence is needed for AI-based devices and why common standards should be utilized.

AI Evidence

Artificial intelligence (AI) technology is widely used in the medical sector, but regulators in the EU and beyond are yet to reach a definitive decision on the best way to regulate this type of software. Indeed, the European Commission has faced much criticism for its proposed AI Act, which is set to be a landmark piece of legislation that sets out sector-agnostic rules for AI products.

But what actually is AI, and how should it be regulated in a medical context? In an 8 May white paper published under the CORE-MD project, experts in EU...

The CORE-MD experts recommend that special provisions for AI-related aspects of each risk class of medical device according to the EU Medical Device Regulation “would best be an integral part...

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TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Mirvie Launches Predictive Blood Test For Preeclampsia

 
• By Marion Webb

Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.

Digital Health And AI Tools Advance Cardiac Event Prediction, SCAI 2025 Data Show

 
• By Shubham Singh

Out-of-hospital cardiac arrest remains one of the most challenging and resource-intensive emergencies in cardiovascular care. At SCAI 2025, clinicians presented a novel algorithm that improved triage decisions and reduced unnecessary interventions.

SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
• By Marion Webb

Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.

More from Digital Technologies

Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 
• By Natasha Barrow

King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.

Synchron And Apple Team Up To Use ‘Mind-Thought Connection’ To Control iPhones, iPads

 
• By Marion Webb

Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.

Ketryx Wants Its Validated AI Agents To Accelerate Compliance Workflows

 
• By Shubham Singh

While the initial focus is medical devices and life sciences, Ketryx sees future opportunities in other high-regulation sectors including automotive, aerospace and defense, pharma manufacturing and nuclear systems.