1. Medtech Insight
  2. >>Policy & Regulation

CMS Considers Coverage For GE’s Risk-Predictor Tool For Sudden Cardiac Death

The Medicare agency says it is reconsidering a 2008 national noncoverage policy for GE Healthcare’s microvolt T-Wave alternans testing tool for evaluating risk of sudden cardiac death, and the potential need for an ICD. An alternative MTWA technique is already covered, but the company that makes that product is going out of business.

CMS is taking another look at GE Healthcare’s ambulatory electrocardiogram analysis tool that could assess patients’ need for a primary-prevention implantable cardioverter defibrillator.

In 2008, the Medicare agency issued a national noncoverage policy for GE’s method for measuring so-called microvolt T-Wave alternans to...

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
Start Free Trial

Already a subscriber?

More from Policy & Regulation

More from Medtech Insight

India’s MedTech Future Hinges On Regulatory Reform And Global Alignment: MTaI’s Pavan Choudary

 
• By Shubham Singh

In this in-depth interview with Medtech Insight, Pavan Choudary unpacks the implications of recent free trade agreements (FTAs) such as India’s with the UK, the potential fallout from new US tariffs on Indian device exports, and the pressing need for regulatory harmonization.

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

European Medtechs Reiterate Opposition To Reciprocal Tariffs On US Imports

 
• By Ashley Yeo

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.