The UK Medicines and Healthcare products Regulatory Agency has issued guidance on the pre- and post-market clinical evaluation of leadless cardiac pacemakers, a type of technology that the regulator says is not yet well-established and for which no specific product standards exist.
European CE markings for leadless pacemakers have to date been issued on the basis of limited clinical data, in terms of both the number of patients included in clinical studies...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?