Tag: US FDA
“The tables have turned”—US FDA regulation is becoming the envy of...
Discussions at this year’s European Society of Minimally Invasive Neurological Therapy (ESMINT) congress (4–6 September, Marseille, France) revealed the extent of the disparities between the...
Early Feasibility Study programme has potential to advance US neurovascular space
At a time when many of Europe’s medical technology markets are effectively going backwards due to complications created by the EU Medical Device Regulation...
CELLO II balloon guide catheter gains US FDA approval for peripheral...
The CELLO II balloon guide catheter (Fuji Systems Corporation) has received 510(k) premarket approval from the US Food and Drug Administration (FDA), and can...
Swiss parliament votes to accept US FDA-approved medical devices
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion...
FDA issues two final guidances for including patient perspectives in medical...
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.
As...
NeuroPace gains IDE approval to launch pivotal study of neuromodulation therapy...
NeuroPace has announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate the NAUTILUS...
Rapid Medical to initiate trial expanding thrombectomy treatment across distal regions...
Rapid Medical today announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for what it claims is the first ever trial...
Medtronic recalls Pipeline Flex embolisation devices over risk of delivery system...
Medtronic has issued a recall of its Pipeline Flex embolisation device and Pipeline Flex embolisation device with Shield technology products due to a risk...
Neuros Medical completes enrolment in QUEST pivotal study of novel post-amputation...
Neuros Medical—a medical device company developing novel high-frequency nerve block technology for patients with intractable post-amputation pain—has announced the completion of enrolment in its pivotal QUEST...
Qure.ai lands second FDA clearance for AI-based brain scan technology
Qure.ai has announced US Food and Drug Administration (FDA) 510(k) clearance for its brain computed tomography (CT) quantification product qER-Quant. Clinicians in the USA...
FRED flow diverter safe and effective in treatment of “appropriately selected”...
The Flow Redirection Endoluminal Device stent system (FRED; MicroVention)—a flow diverter used to treat intracranial aneurysms—has been deemed safe and effective for this indication,...
Synchron given green light to begin US study of endovascular brain-computer...
The Stentrode motor neuroprosthesis, developed by Synchron, has taken another step towards becoming the world’s first commercially available, endovascular brain-computer interface (BCI) technology after...
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 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 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’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...
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 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 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)...
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: 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 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 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...
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...
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...
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...
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...
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 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 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...
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 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...
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...
