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Device Designed To Improve Spine-Surgery Outcomes Gets FDA Panel Date

 
• By David Filmore

US FDA says its Orthopaedic and Rehabilitation Devices Panel will convene Dec. 12 to weigh issues surrounding ongoing review of Intrinsic Therapeutics' PMA for its Barricaid anular closure device, intended to close a hole created by a spine discectomy procedure to prevent negative outcomes.

Intrinsic Therapeutics Inc. says a 554-patient randomized, superiority trial supports use of its Barricaid device following a standard spine procedure to prevent re-herniation and recurrence of pain or dysfunction. In December, a US FDA advisory panel will weigh the evidence.

The agency issued a notice Oct. 16 announcing that its Orthopaedic and Rehabilitation Devices Panel will meet Dec. 12 to...

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More from Approvals

A Decade Of Breakthrough Devices: Cardiac And Orthopedic Products Dominate FDA Designations

 
• By Brian Bossetta and Elizabeth Orr

The US FDA has provided an update on its breakthrough devices program, now 10 years running. Cardiac, orthopedic, and neurological devices have received the most designations, while only one has been awarded to an obstetrics/gynecology product.

Four-Year Waits, 60-Page NCDs: Consultant Urges Medicare Overhaul

 
• By Elizabeth Orr

Medicare’s device coverage process is “a system in crisis,” consultant Bruce Quinn warned at the NextGen Dx Summit. He criticized bloated NCDs, stalled advisory committees, and years-long delays, urging CMS to streamline LCDs and adopt a six-month “fast-track” model to speed innovation access.

Dexcom Nabs Weight Management Indication For Signos CGM

 
• By Malcolm Spicer

Signos links users to Dexcom’s Stelo for glucose readings and historic trends. The app is available in iOS and Android from the firm’s website, where it’s priced at $139 for three-month plan and $129 for a two-month plan, or online app stores.

NeuroOne Prepares To Launch Trigeminal Nerve Ablation System

 
• By Elizabeth Orr

The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.

More from Policy & Regulation

Medical Device Recalls Down In Q1 For Lowest Quarterly Count In 3 Years. But Will It Last?

 
• By Brian Bossetta

Despite a surge in product recalls across five key industries in the first quarter of the year, medical device recalls were down, according to Sedgwick’s latest recall index. But the firm noted they’ve since ticked up.

Dexcom Nabs Weight Management Indication For Signos CGM

 
• By Malcolm Spicer

Signos links users to Dexcom’s Stelo for glucose readings and historic trends. The app is available in iOS and Android from the firm’s website, where it’s priced at $139 for three-month plan and $129 for a two-month plan, or online app stores.

German Health Researchers Prep for Possible Disruptions to PubMed, ClinicalTrials.gov

 
• By Elizabeth Orr and Francesca Bruce

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.