1. Medtech Insight

US FDA and CMS launch parallel review pilot for medical devices

 
• By Vibha Sharma

The US Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) have launched a voluntary pilot programme in which the agencies will conduct concurrent reviews of medical devices for FDA approval and Medicare coverage, in a bid to expedite patient access to products.

The US Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) have launched a voluntary pilot programme in which the agencies will conduct concurrent reviews of medical devices for FDA approval and Medicare coverage, in a bid to expedite patient access to products.

The two-year, parallel review programme had originally been proposed in September 2010 and, according to the agencies, it has now been modified in light of concerns expressed by industry. Some...

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 Archive

More from Medtech Insight

Execs On The Move: 5-9 May 2025

 
• By Medtech Insight Team

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

TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.