Tag: FDA

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The US Food and Drug Administration (FDA) released the following two draft guidance documents: These guidance documents provide industry and FDA staff with recommendations on...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...