1. Medtech Insight

Saluda’s Evoke SCS Set To Join Competitive US Spine-Stim Market In Late 2022

 
• By Reed Miller

The Australian company secured $125m in financing to support commercialization of the Evoke SCS system for chronic pain beginning in late 2022. The US FDA approved Evoke SCS for chronic intractable pain of the trunk and/or limbs, the third major FDA approval of an SCS technology this year so far.

Competition
• Source: Shutterstock

Saluda is preparing to market the Evoke SCS system in the US as the only available SCS system that treats chronic pain by instantaneously reading and reacting to the nerves’ response to stimulation.

On 8 March, the Sydney-based company announced the US Food and Drug Administration

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 Approvals

More from Policy & Regulation

FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By Elizabeth Orr

A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 
• By Brian Bossetta

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

Does Makary’s Reorg Choice Mark FDA Turning Point?

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.