The atrial fibrillation market has attracted the attention of a large number of established and emerging cardiovascular device companies over the past several years, all hoping to cash in on the huge demand for a simple, safe, and effective therapy that can permanently cure this common, and often debilitating, heart arrhythmia. Most of the research to date has focused on energy-based methods both surgical and percutaneous - to destroy aberrant electrical triggers in the heart that are believed to initiate and perpetuate AF. But no one has yet received FDA approval for a catheter-based ablation tool, a milestone that is widely recognized as key to full penetration of this market. To be sure, they have come close. But obtaining an FDA indication for the more complex AF ablation procedure has proven a much more difficult goal.
by Mary Thompson
Atrial fibrillation (AF) is a market that has attracted the attention of a large number of established and emerging cardiovascular device companies over the past several years, all hoping to...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
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.
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.
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.
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.
Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.
German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.
Medtronic expects operating profit to grow approximately 7% in fiscal 2026, excluding tariff impacts. If tariffs materialize at the upper end of the projected range, operating profit growth could drop by 2.2 to 3.2 percentage points.