Tag: hydrocephalus
Cerevasc’s eShunt system receives US FDA Breakthrough Device designation for use...
Cerevasc announced recently that it has received its second Breakthrough Device designation from the US Food and Drug Administration (FDA) for its investigational eShunt...
Cerevasc announces first patient randomised to eShunt system treatment in STRIDE...
Cerevasc has announced that the first patient has been randomised to and treated with the eShunt system in its STRIDE clinical trial—a head-to-head comparison of...
STRIDE trial assessing eShunt treatment for normal-pressure hydrocephalus gains approval in...
Cerevasc announced recently that it has received approval from Argentina's National Administration of Drugs, Food and Medical Devices (ANMAT) to initiate the STRIDE trial—a...
Cerevasc announces positive eShunt study results in elderly NPH patients
Cerevasc has today reported initial results from its pilot US Food and Drug Administration (FDA)-approved investigational device exemption (IDE) clinical study of the eShunt...
EShunt system receives US FDA Breakthrough Device designation for hydrocephalus treatment
Cerevasc has announced it has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its eShunt system, which is intended...
Cerevasc highlights eShunt study presentations from ABC WIN Seminar
Cerevasc has announced that data from clinical studies in the USA and Argentina examining the use of its eShunt system to treat communicating hydrocephalus were presented at...
Hyperfine completes enrolment for pilot study assessing portable MRI in paediatric...
Hyperfine has announced completed enrolment for HOPE PMR—a multicentre, observational pilot study assessing portable magnetic resonance imaging (MRI) in children with neurological injury, using...
Anuncia announces first successful implant of ReFlow mini flusher in hydrocephalus...
Anuncia Medical has announced the successful first implant of the company's US Food and Drug Administration (FDA)-cleared ReFlow mini flusher device.
Performed on by neurosurgeon Samuel...
Anuncia announces US launch of second-generation ReFlow device to treat hydrocephalus
Anuncia Medical has announced the successful US commercial launch of the ReFlow mini flusher—a second-generation device for the treatment of hydrocephalus. According to a...
US and Chinese experts introduce new aneurysmal subarachnoid haemorrhage guidelines
Expert groups from the USA and China have separately introduced new guidelines relating to the management of aneurysmal subarachnoid haemorrhage (aSAH). The updated guidelines—spearheaded...
Anuncia announces publication of “promising” hydrocephalus outcomes with ReFlow ventricular system
Anuncia Medical has announced that an article highlighting its US Food and Drug Administration (FDA)-cleared and CE-marked ReFlow ventricular system (Gen 1) with hydrocephalus...
Rhaeos raises US$10.5 million in Series A funding to boost hydrocephalus...
Rhaeos has announced the successful closing of US$10.5 million in Series A funding, led by the Steele Foundation for Hope, bringing the company’s total funding to more...
Pedro Lylyk
Pedro Lylyk’s work and achievements in the neurosurgical field have spanned several decades, and range from a momentous intracranial stent placement in 1996, to...
CereVasc receives FDA nod to study eShunt system in normal-pressure hydrocephalus...
CereVasc has announced that the US Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) application to initiate a pilot trial...
CereVasc announces publication of first-in-human case report with eShunt system
CereVasc has announced the publication of a case report detailing the first treatment in a study of its eShunt system—an investigational device intended to...
Rhaeos awarded US$4 million NIH grant to expand sensor technology for...
Rhaeos has been awarded a US$4 million, multi-year grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) programme through the...
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...
First patient treated in eShunt clinical trial
CereVasc has announced the treatment of the first patient in a study of its eShunt System, an investigational device intended to treat communicating hydrocephalus...