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EU MEDDEV guide on post-market clinical follow-up studies updated

 
• By Vibha Sharma

The European Commission has issued updated guidance for medical device manufacturers and notified bodies on how to conduct post-market clinical follow-up (PMCF) studies. Such studies are one of several options available to manufacturers to fulfil their post-market surveillance obligations.

The European Commission has issued updated guidance for medical device manufacturers and notified bodies on how to conduct post-market clinical follow-up (PMCF) studies. Such studies are one of several options available to manufacturers to fulfil their post-market surveillance obligations.

The updated guideline, MEDDEV 2.12/2 rev2, provides guidance on the appropriate use and conduct of PMCF studies to address issues...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

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Execs On The Move: June 16–20, 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Dxcover Launches US Operations With New Headquarters In Tennessee

 
• By Natasha Barrow

Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.

EnsoData Boosts AI Sleep Tech With $20M Series B Funding, Targets Underdiagnosis Crisis

 
• By Shubham Singh

EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.