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...

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

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By 

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By 

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.

US House Budget Sets FDA FY26 Funding At $3.2B

 

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

More from Medtech Insight

Three Steps To Investor Heaven For Medtech Founders: Articulate, Explain, Clarify

 
• By 

Capital remains available for good healthtech projects, but it is more concentrated and harder to find than of late. Founders and inventors must know how to unlock it. The BioWales 2025 investor panel told them where they could be going wrong.

Aneira Health Launches New Precision Medicine Platform Exclusively For Women

 

Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.

AI In Health Delivery: Patients Most Confident When HCPs Are In Charge

 
• By 

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.