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

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
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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.

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First At-Home Test For Multiple STIs Gets FDA Clearance

 
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Quibim Extends Into US Market With FDA Authorization Of QP-Prostate CAD

 

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Dexcom Eyes US FDA Clearance For 15-Day CGM, But Insurance Coverage Remains Uncertain

 
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Sebela’s Miudella Is First Hormone-Free IUD To Win FDA Approval In 40 Years

 
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The device, which uses a flexible frame to ease insertion and minimize the dose of copper, is 99% effective in preventing pregnancy. Clinical trial lead David Turok said it represents “a real advance” in contraceptive options.

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Global Medtech Guidance Tracker: March 2025

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Whitaker Wants Congress To Capitalize On ‘Golden Age Of Medical Innovation’

AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.

First At-Home Test For Multiple STIs Gets FDA Clearance

 
• By 

The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.