CMS Targets Leadless Pacers For Medicare Coverage Analysis

The Medicare agency signaled that it plans to establish a national coverage policy for leadless pacemakers in a memo issued May 18. The memo comes about one month after FDA approved the first such product, Medtronic’s Micra transcatheter leadless single-chamber pacemaker.

The Medicare agency signaled that it plans to establish a national coverage policy for leadless pacemakers in a memo issued May 18. The memo comes about one month after FDA approved the first such product, Medtronic’s Micra transcatheter leadless single-chamber pacemaker.

Leadless pacers are intended to deliver pacemaker therapy without the need to insert wires through a patient's veins into the...

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

More from Policy & Regulation

Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
• By 

The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 

Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.

Experts Call For Database Of Medical Device Labels

 
• By 

A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.

EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 

EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.

More from Medtech Insight

Execs On The Move: July 7–11, 2025

 
• By 

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

EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 

EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.

‘Eyes – A Window Into The Heart’: Retinal AI Tool Predicts Future Risk Of Heart Attack And Stroke

 

A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.