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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 a May 8 notice to providers. Following several adverse...

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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.

Synchron And Apple Team Up To Use ‘Mind-Thought Connection’ To Control iPhones, iPads

 
• By Marion Webb

Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.

Axoft Starts Commercializing Soft BCI-Enabling Materials For R&D Use, Aims To Rewrite BCI Playbook

 
• By Marion Webb

After publishing encouraging results from first-in-human trials of its brain-computer interface, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use. The company sees this as a revenue stream and feedback loop to refine its BCI platform designed for safer, longer-lasting brain implants.

More from Device Area

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.