The European Commission’s proposed Artificial Intelligence Act has undergone some adaptations over the past year, but concerns remain around its impact on the medtech sector. In this interview, Philips’ Koen Cobbaert outlines the current situation and challenges.
The EU Artificial Intelligence (AI) Act is a proposed horizontal piece of legislation that will introduce regulatory requirements for any product based on machine-learning technology, including medical devices and health tech.
Koen Cobbaert, senior manager, quality, standards, and regulations at Philips, has spoken again with Medtech Insight to discuss what changes...
J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.
Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.
J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.
The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
