1. Medtech Insight
  2. >>Policy & Regulation

Add-On Payment Accelerates Commercialization Of NeuroPace’s RNS

The company is focused on expanding the number of centers that use its responsive neurostimulator RNS system to treat seizures in patients with epilepsy, while eyeing other indications. It’s also partnering with the Defense Department on a memory restoration project.

A recently awarded Medicare new-technology add-on payment for NeuroPace Inc.RNS responsive neurostimulator system could provide a major boost to the company’s efforts to bring the anti-seizure therapy to all of the top epilepsy centers in the U.S., CEO Frank Fischer said in an interview.

RNS became the first responsive implantable neurostimulator commercially available in the U.S. in November 2013. FDA approved the device to reduce the frequency of seizures in certain adults with epilepsy...

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

Siemens Healthineers Widens FY25 EPS Range By €0.15 To Absorb Up To €300M In Tariff Costs

 
• By Shubham Singh

The imaging, Varian, and advanced therapies segments – which are more reliant on equipment sales – are more heavily affected, with tariffs applying to roughly 55% of their revenue base. In diagnostics, the company expects minimal exposure due to sufficient US value-added manufacturing.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
• By Marion Webb

Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.