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FDA Urges Caution in Some Neurovascular Stent Use

 
• By Elizabeth Orr

US FDA has issued new guidelines to providers because some patients experienced strokes or died after being treated for unruptured brain aneurysms with some neurovascular stents.

Editor's Note: This story has been updated to add additional context from Stryker.

Some brain aneurysm patients may experience a higher stroke risk when treated with certain neurovascular stents, US FDA warned in...

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Abbott Launches Next-Gen Delivery System For Proclaim DRG Neurostim

 
• By Shubham Singh

Allen Burton, Abbott’s medical director of neuromodulation told Medtech Insight that the delivery system was developed to make the procedure easier for physicians, especially those who perform the implantations infrequently.

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

 
• By Marion Webb, Brian Bossetta, Natasha Barrow, Elizabeth Orr, and Shubham Singh

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

Salvia Bioelectronics Secures $60M In Series B To Advance Chronic Migraine Implant, Eyes US Trials

 
• By Marion Webb

Medtech Insight spoke with Hubert Martens, CEO of Netherlands-based neuromodulation company Salvia Bioelectronics, about the company’s innovative implant for treating chronic migraines, ongoing clinical trials and plans for US clinical trials and commercialization.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

More from Device Area

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

 
• By Marion Webb, Brian Bossetta, Natasha Barrow, Elizabeth Orr, and Shubham Singh

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

GE HealthCare Announces US Launch Of Longer Half-Life PET MPI Agent For Ischemia Detection

 
• By Shubham Singh

GE HealthCare is pursuing a dual-front imaging strategy with its PET MIP agent Flyrcado for detecting artery disease: It lasts longer than current PET scan tracers and allows patients to do treadmill-based stress tests alongside the scan.