Tag: 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...
US FDA seeks to “modernise” clinical trials with new draft guidance
The US Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernising the design...
NeuroOne submits special 510(k) to US FDA for Evo sEEG electrode
NeuroOne Medical Technologies has announced the submission of a special 510(k) to the US Food and Drug Administration (FDA) for its stereoelectroencephalography (sEEG) electrode...
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...
Neuromod Devices appoints Diarmuid Flavin as COO to boost expansion of...
Neuromod Devices has announced the appointment of Diarmuid Flavin as chief operating officer (COO). Flavin brings more than 25 years of global leadership experience...
Allegheny Health Network initiates clinical trial exploring use of DBS to...
A team of physicians at Allegheny Health Network (AHN) in Pittsburgh, USA has received US Food and Drug Administration (FDA) approval to begin the...
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...
Medtronic gains FDA approval to trial implantable tibial neuromodulation device
Medtronic has announced approval from the US Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate its...
Cerus Endovascular announces Contour Neurovascular System™ IDE trial approval
Cerus Endovascular has announced that the US. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to conduct a US...
CerusEndo MC 021 microcatheter wins CE mark
Cerus Endovascular has announced that it has received CE mark approval for its CerusEndo MC 021 microcatheter, designed to allow physicians to access tortuous...
Mainstay Medical announces FDA approval of ReActiv8 neurostimulation system for chronic...
Mainstay Medical has announced that the US Food and Drug Administration (FDA) has approved the company’s premarket approval (PMA) application for ReActiv8, its implantable...
MIVI Neuroscience receives IDE approval to study the Q aspiration catheter
MIVI Neuroscience has announced today that the US Food and Drug Administration (FDA) has approved an investigational device exemption for the initiation of a...
CDRH adjusts working practices with medical device companies to deal with...
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has written to the medical device industry to outline its...
Cerus Endovascular receives FDA Approval for its first microcatheter
Cerus Endovascular receives US FDA approval for its first microcatheter. The 021 microcatheter will be offered with three different distal configurations, and commercial sales...
Axonics announces FDA approval for the use of full-body MRI for...
Axonics have announced that the Food & Drug Administration (FDA) approved the use of full-body magnetic resonance imaging (MRI) using 1.5 Tesla MRI scanners...
Canon Medical receives FDA clearance for deep convolutional neural network image...
Building on its advanced image reconstruction technologies, Canon Medical Systems USA has received 510(k) clearance on its new deep convolutional neural network (DCNN) image...
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...
Medtronic’s deep brain stimulation for medically-refractory epilepsy launches in the USA
Medtronic has announced both the US launch of deep brain stimulation (DBS) for medically-refractory epilepsy and the first commercially implanted patient at Emory University...
Corindus announces FDA submission for neurovascular intervention indication for CorPath GRX
Corindus Vascular Robotics announces that it is seeking premarket clearance from the US Food and Drug Administration (FDA) to use the CorPath GRX System...
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...
Novel intrasaccular aneurysm treatment device receives FDA PMA approval
MicroVention has announced that the FDA premarket approval (PMA) for the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms....
Nuvectra receives full-body MR-conditional CE Mark approval for Algovita
Nuvectra has announced that it has received full-body MR-conditional approval for the Company’s Algovita spinal cord stimulation (SCS) system from its European Notified Body,...
Nuvectra receives FDA head-only MR-conditional approval for Algovita
Nuvectra has announced that it has received US Food and Drug Administration (FDA) head-only MR-conditional approval for the company’s Algovita spinal cord stimulation (SCS) system.
Scott...
US FDA plan shakeup of its 510(k) clearance programme
The US FDA has announced plans to modernise its 510(k) clearance programme for approving medical devices for the US market. Data show that about...
Monteris Medical announces FDA clearance of NeuroBlate Optic laser probe
Monteris Medical has announced it has received clearance from the US Food and Drug Administration (FDA) for its NeuroBlate Optic laser probe, a laser...
Innovative on-ambulance PHAST-TSC trial for treatment of acute stroke approved by...
Diffusion Pharmaceuticals, a biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where...
US FDA issues draft guidances for recommended premarket testing and labelling...
The US Food and Drug Administration (FDA) released the following two draft guidance documents: These guidance documents provide industry and FDA staff with recommendations on...
FDA cautions about risks of coiling for brain aneurysms
After reports of periprocedural stroke and death with the use of neurovascular stents for stent-assisted coiling (SAC), the US FDA issued a safety alert...
Neurovascular embolisation coils: potential for increased image artifact when using magnetic...
Information reviewed by the FDA, indicates that when magnetic resonance angiography (MRA) is performed on patients implanted with neurovascular embolisation coils containing 304V stainlesss...
New blood test detects traumatic brain injury—not concussion
A new blood test approved by the Food and Drug Administration is being characterised by the agency and news reports as a way to...
FDA expands treatment window for use of clot retrieval devices in...
The US Food and Drug Administration has cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24...
FDA authorises marketing of first blood test to aid in the...
The US Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to...
FDA permits marketing of software that may alert doctors of stroke...
The US Food and Drug Administration have permitted the marketing of the Viz.AI Contact application, a type of clinical decision support software designed to...
First neonatal magnetic resonance imaging device cleared by US FDA
The US Food and Drug Administration (FDA) has cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in...
LivaNova’s VNS Therapy receives FDA approval for expanded MRI labelling
LivaNova’s latest vagus nerve stimulation (VNS Therapy) system has received US Food and Drug Administration (FDA) approval for expanded magnetic resonance imaging labelling.
According...
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...
US FDA grants IDE approval to Monteris Medical for glioblastoma multiforme...
The US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) to Monteris Medical to evaluate the NeuroBlate system in patients...
US FDA broadens treatment indication for Stryker’s Trevo device
The US Food and Drug Administration (FDA) has allowed marketing of two Trevo (Stryker Neurovascular) clot retrieval devices as an initial therapy for ischaemic...
