Washington Roundup, May 2012

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we report on the new Medicare coverage policy for transcatheter aortic valve replacement and Medicare latest hospital inpatient payment proposal.

A national Medicare coverage policy is now set for transcatheter aortic valve replacement (TAVR), stabilizing the reimbursement environment for the new procedure, but also establishing a level of payor restrictions that is rare for a technology so early in its life cycle.

The TAVR procedure, an alternative to open heart valve surgery, is being touted as practice-changing by cardiologists and a blockbuster...

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 United States

Inaccurate Carbon Dioxide Readings Prompt Class I Recall Of Draeger Ventilation Filters

 

Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By 

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

Apreo Health Raises $130M, First Patient Treated In US Clinical Trial

 

Apreo Health CEO Karun Naga talks to Medtech Insight about the company’s intentions for its Series B funding. The Breathe-3 clinical trial and early commercialization activities, involving physician education, are top priorities.

NAD Alerts Agendia Over Endorsing Physician’s Ties To Firm

 
• By 

The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.

More from North America

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.

Exact Sciences Reveals Thinking On CRC Liquid Biopsy After Freenome Deal

 

Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.

FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.