Tag: US FDA

quicktome omniscient neurotechnology

Omniscient Neurotechnology launches Quicktome brain-mapping platform following FDA clearance

Omniscient Neurotechnology has received US Food and Drug Administration (FDA) 510(k) clearance for Quicktome—a digital brain-mapping platform that allows neurosurgeons to visualise and understand...
nevro senza

Nevro announces FDA approval of 10kHz high-frequency SCS therapy for painful...

Nevro has announced receipt of US Food and Drug Administration (FDA) approval for its Senza system for the treatment of chronic pain associated with...
neuros medical altius

Neuros Medical gains FDA Breakthrough Device designation for Altius nerve block...

Neuros Medical has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for the use of its novel, high-frequency nerve block...
sensome

Sensome’s AI-powered stroke guidewire granted FDA Breakthrough Device designation

Sensome has announced its Clotild Smart Guidewire System—designed to improve the treatment of ischaemic stroke patients—has been granted a Breakthrough Device designation by the...
pons fda approval

Neuromodulation device for treating MS-related gait deficit receives FDA authorisation

Cambridge Consultants and Helius Medical Technologies have confirmed their “groundbreaking" Portable Neuromodulation Stimulator (PoNS) device—developed for the short-term treatment of gait deficit due to...
medtronic vanta

Medtronic announces FDA approval of recharge-free Vanta spinal cord stimulation implant

Medtronic has received US Food and Drug Administration (FDA) approval for Vanta—a high-performance, recharge-free implantable neurostimulator (INS) with a device life that can be...
vesalio

Vesalio initiates new FDA stroke study following “milestone” VITAL trial enrolment

US medical device company Vesalio has announced the start of enrolment in the Vesalio CLEAR study—an acute ischaemic stroke FDA investigational device exemption (IDE)...
rapid medical TIGERTRIEVER

First US ischaemic stroke patients treated with Rapid Medical’s novel clot...

The first US patients have been treated with the FDA-cleared TIGERTRIEVER revascularisation device (Rapid Medical). TIGERTRIEVER is the first physician-adjustable stent retriever, according to...
IpsiHand System

IpsiHand System: New device for facilitating stroke rehabilitation gains FDA approval

The US Food and Drug Administration (FDA) has authorised marketing of a new device indicated for use in patients aged 18 and older undergoing...

Stentrode brain-computer interface receives breakthrough device designation from FDA

The US Food and Drug Administration (FDA) has granted breakthrough device designation to the Stentrode brain-computer interface for its fully-implantable medical device that can...
rapidAI Rapid LVO FDA approval

RapidAI receives FDA clearance of Rapid LVO for identification of suspected...

RapidAI has announced that Rapid LVO has received US Food and Drug Administration (FDA) clearance for detecting suspected large vessel occlusions (LVOs). Rapid LVO helps...
Medtronic

Medtronic announces US launch of its InterStim Micro neurostimulator

Medtronic has announced that its recently US Food and Drug Administration (FDA)-approved InterStim Micro neurostimulator for sacral neuromodulation (SNM) therapy is now available in...
SOMATOM Siemens Healthineers

FDA clears SOMATOM On.site from Siemens Healthineers for CT exams at...

The US Food and Drug Administration (FDA) has cleared the SOMATOM On.site, a mobile head computed tomography (CT) scanner from Siemens Healthineers that enables...
Neuroform Atlas stent system expanded indication

Stryker’s Neuroform Atlas stent approved to treat aneurysms of the posterior...

  Stryker announced that it has received US Food and Drug Administration (FDA) approval for an expanded indication of its Neuroform Atlas stent system as...
Percept PC neurostimulator

FDA approves Percept PC neurostimulator with BrainSense technology

Medtronic has announced it received US Food and Drug Administration (FDA) approval for the Percept PC deep brain stimulation (DBS) system. BrainSense technology makes...
Axonics two year results ARTISAN-SNM study

FDA approval for Axonics’ wireless patient Remote Control with SmartMRI technology

Axonics, a company that has developed implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has announced US Food and...
Squid trial embolisation balt

Balt receives IDE approval to begin the STEM trial

Balt has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin the Squid trial for the embolisation of the middle meningeal...
Axonics two year results ARTISAN-SNM study

Axonics wins FDA approval for its next-generation implantable neurostimulator

Axonics has announced the US Food and Drug Administration (FDA) approval of its next-generation rechargeable implantable neurostimulator for its r-SNM system under a premarket approval...

Rist Neurovascular radial artery catheter receives FDA 510(k) clearance

Rist Neurovascular recently announced that it has received US Food and Drug Administration (FDA) 510(k) clearance to market the Rist Cath Radial Access Long...

Intrasaccular aneurysm treatment device receives US FDA PMA approval

MicroVention, a US-based subsidiary of Terumo and a global neurovascular company, announces the US FDA premarket approval (PMA) for the WEB aneurysm embolisation system...
Axonics two year results ARTISAN-SNM study

Axonics granted six US patents and allowed three additional patents related...

Axonics has announced that the United States Patent and Trademark Office has issued or allowed Axonics nine US utility patents in 2019, along with...
SNM axonics system

Axonics announces first commercial US patient implanted with its sacral neuromodulation...

  Axonics has announced the first US-based implantation of the Axonics r-SNM system subsequent to its clearance by the US Food & Drug Administration (FDA)...
Axonics FDA approval Remote Control

Axonics announces US FDA approval for its sacral neuromodulation system

Axonics, a medical technology company that has developed and is commercialising a novel implantable rechargeable sacral neuromodulation (SNM) device for the treatment of urinary and...

Latest FDA caution for the use of off-label drugs in intrathecal...

While the US Food and Drug Administration (FDA) has called for caution regarding the use of off-label medications administered intrathecally, pain management experts have...

Scott Gottlieb resigns as head of US FDA

The commissioner of the US Food and Drug Administration (FDA), Scott Gottlieb, has unexpectedly resigned after serving just shy of two years in the...
shutdown

US government shutdown disrupting FDA work

The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept new user fees, which means the agency cannot accept new...

FDA approval of Exablate Neuro for the treatment of tremor-dominant Parkinson’s...

InSightec has announced that The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has approved an expansion...

Stimwave receives FDA clearance for first Wireless SCS System with iPhone-iWatch...

Stimwave Technologies has announced that it has received US Food and Drug Administration (FDA) clearance for the WaveCrest Mobile iOS platform patient controllers for...

FDA recalls brain surgery device due to heating problem

The US FDA has alerted doctors to a problem with the Monteris Medical NeuroBlate probe in which the device may become unexpectedly heated during...

Robert Califf to resign as US FDA commissioner

Robert Califf is to step down as US Food and Drug Administration (FDA) commissioner upon the inauguration of Donald Trump as US President on...

NICE collaborates with US FDA on Payer Communication Taskforce

The UK’s National Institute for Health and Care Excellence (NICE) has announced its participation in the US Food and Drug Administration (FDA)’s Payer Communication...