NeuroPace’s RNS For Epilepsy Becomes First FDA-Approved Responsive Neurostimulator

While standard neurostimulators are open-loop systems that stimulate continuously or intermittently according to preprogramming, RNS is a more targeted, closed-loop system that monitors brain activity in real time and provides electrical stimulation to interrupt troubling patterns that might cause a seizure.

FDA approved NeuroPace Inc.’s RNS neurostimulator system Nov. 14 for drug-refractory epilepsy. It is the first responsive neurostimulator device approved by the agency, intended to detect abnormal brain activity and normalize it before a patient experiences a seizure.

While standard neurostimulators are open-loop systems that stimulate continuously or intermittently according to preprogramming, RNS is a more targeted, closed-loop...

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 Regulation

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 

Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By 

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

More from Policy & Regulation

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By 

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.