Artificial intelligence is incorporated into medical devices and IVDs with increasing frequency. But it is only now that the EU is working on how that process will be regulated.
The European Commission is proposing the first ever legal framework on artificial intelligence and has made it clear that its new AI regulation will impact medical devices and IVDs which make use of AI. Indeed, such products will be considered high-risk.
The proposal for an Artificial Intelligence Regulation is 108-pages long. It is accompanied by an additional nine annexes spread over 17 pages that are mainly related to technical documentation and...
TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.
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.
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.
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.
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.
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.
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.
