Normal pressure hydrocephalus

QuantalX Secures Spot in FDA's Prestigious Total Life Cycle Advisory Program (TAP)

Retrieved on: 
Thursday, April 4, 2024
Diagnosis, NPH, Movement disorder, Growth, Cerebrospinal fluid, CSF, Risk, Patient, DSM-IV codes, Stroke, TAP, Doctor of Philosophy, Medtronic, Science, Approximation error, Normal pressure hydrocephalus, Food, FDA, VPS, Dementia, Pharmaceutical industry

NEW YORK, April 4, 2024 /PRNewswire/ -- QuantalX Neuroscience, a pioneering healthcare company dedicated to early detection of brain disorders using the Delphi-MD medical device, announced today its selection to participate in the highly prestigious Total Life Cycle Advisory Program (TAP) initiated by the U.S. Food and Drug Administration (FDA). The program will focus on advancing Delphi-MD's unique Direct Electrophysiology Imaging technology, enabling the early detection of Normal Pressure Hydrocephalus (NPH) disease, with high accuracy rates, and the prediction of patients' response to ventriculoperitoneal shunting (VPS). The TAP program brings together the FDA, major health insurers, healthcare organizations, and industry leaders in a collaborative effort to construct a comprehensive strategy for technologies that can benefit the general population. This strategic framework spans crucial elements, such as value creation in the U.S. market, meticulous preparation for regulatory approval, meaningful engagement with insurers, and the establishment of a robust market presence with customers.

Key Points: 
  • NEW YORK, April 4, 2024 /PRNewswire/ -- QuantalX Neuroscience, a pioneering healthcare company dedicated to early detection of brain disorders using the Delphi-MD medical device, announced today its selection to participate in the highly prestigious Total Life Cycle Advisory Program (TAP) initiated by the U.S. Food and Drug Administration (FDA).
  • "The acceptance into the Total Life Cycle Advisory Program is a truly prestigious and significant opportunity for QuantalX," remarked Iftach Dolev.
  • The Total Life Cycle Advisory Program aims to guide innovative technologies through the entire product life cycle, ensuring regulatory compliance, market adoption, and enhanced positive patient impact.
  • The valuable experience and insights within this program are expected to accelerate QuantalX's market entry and establish a solid foundation for future growth.

Microbot Medical to Present the Self-Cleaning Shunt at the 16th Asian Australasian Congress of Neurological Surgeons

Retrieved on: 
Thursday, August 18, 2022
FDA, CSF, Regulation of tobacco by the U.S. Food and Drug Administration, Intellectual property, Federal, U.S. Securities and Exchange Commission, Forward-looking statement, NPH, GLOBE, Failure, Technology, Private Securities Litigation Reform Act, Growth, SEC, Catheter, Brain, Shaare Zedek Medical Center, Learning, EFS, Congress, Security (finance), SCS, Research, Cerebrospinal fluid, Obstruction, Patient, COVID-19, Company, NASDAQ, Neurology, Maintenance, Physician, Goal, Hydrocephalus, Nasdaq, Normal pressure hydrocephalus, Food, Pharmaceutical industry, Medical device, Microbotics

HINGHAM, Mass., Aug. 18, 2022 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), announced that it will be presenting the Companys Self-Cleaning Shunt (SCS) at the 16th Asian Australasian Congress of Neurological Surgeons(AACNS).

Key Points: 
  • HINGHAM, Mass., Aug. 18, 2022 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), announced that it will be presenting the Companys Self-Cleaning Shunt (SCS) at the 16th Asian Australasian Congress of Neurological Surgeons(AACNS).
  • The AACNS is hosted by the Israel Neurosurgery Society and is being held from September 6th 8th in Jerusalem, Israel.
  • Microbot Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, focused primarily on both natural and artificial lumens within the human body.
  • Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law.

CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System

Retrieved on: 
Tuesday, August 9, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CSF, Literature, CEO, NPH, Lists of diseases, Sale, Tufts Medical Center, Patient, CH, Safety, Doctor of Philosophy, IDE, Physician, Hydrocephalus, Normal pressure hydrocephalus, Food, Subarachnoid hemorrhage, Pharmaceutical industry, Neurosurgery, MD

BOSTON, Aug. 9, 2022 /PRNewswire/ -- CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). 

Key Points: 
  • "We are excited to receive IDE approval from FDA to conduct a second pilot study in the US of the eShunt System in patients who develop hydrocephalus following subarachnoid hemorrhage.
  • Enrolling in parallel with our first IDE study in patients with Normal Pressure Hydrocephalus (NPH), this study will allow us to further examine the safety and efficacy of the eShunt System in a second etiology of hydrocephalus, both of which present a number of management challenges to physicians," said Dan Levangie, Chairman and CEO of CereVasc.
  • Its flagship product, the eShunt System, is intended to offer the first minimally invasive treatment for communicating hydrocephalus (CH) and an improvement to the current standard of care.
  • The patented eShunt System includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components, which are designed to treat CH without invasive surgery.

Anuncia Inc. Receives FDA "Breakthrough Device Designation" for ReFlow™ System Mini

Retrieved on: 
Tuesday, March 2, 2021
Healthcare reform in the United States, Federal assistance in the United States, Presidency of Lyndon B. Johnson, Ventricular system, Health, Branches of biology, Child poverty, Medicaid, Medicare, Reflow soldering, Hydrocephalus, Normal pressure hydrocephalus

Elsa Abruzzo, President of Anuncia Inc., stated, "Our team is very pleased to achieve this significant milestone making the ReFlow System Mini eligible for prioritized FDA regulatory review and Centers for Medicare and Medicaid (CMS) Medicare Coverage of Innovation Technology (MCIT) reimbursement review."

Key Points: 
  • Elsa Abruzzo, President of Anuncia Inc., stated, "Our team is very pleased to achieve this significant milestone making the ReFlow System Mini eligible for prioritized FDA regulatory review and Centers for Medicare and Medicaid (CMS) Medicare Coverage of Innovation Technology (MCIT) reimbursement review."
  • "The ReFlow System Mini is optimized to serve a broad hydrocephalus populationinfants with non-communicating hydrocephalus, young women with pseudotumor cerebri, and older patients with communicating, idiopathic normal pressure hydrocephalus (iNPH).
  • The ReFlow System Mini is under development and not available for sale.
  • The ReFlow System is a prescription device sold by or on the order of a physician.

Congress to Recognize September as Hydrocephalus Awareness Month

Retrieved on: 
Monday, September 28, 2020
Ventricular system, Paradoxidoidea, Articles, Branches of biology, Health, Hydrocephalus, Pediatrics, RTT, Normal pressure hydrocephalus

Thats why the U.S. House of Representatives has recognized September as Hydrocephalus Awareness Month.

Key Points: 
  • Thats why the U.S. House of Representatives has recognized September as Hydrocephalus Awareness Month.
  • Many people with hydrocephalus suffer from other co-occurring conditions, particularly seniors who have Normal Pressure Hydrocephalus.
  • Founded in 1983 by the parents of children with hydrocephalus, the Hydrocephalus Association (HA) is the nations largest and most widely respected organization dedicated to hydrocephalus.
  • The Hydrocephalus Association's mission is to find a cure for hydrocephalus and improve the lives of those impacted by the condition.

Lisa Genova, Ph.D joins CereVasc Board of Directors

Retrieved on: 
Wednesday, January 16, 2019
Ventricular system, Lisa Genova, Hydrocephalus, Normal pressure hydrocephalus, Neuroscientist, Medicine, Health, Nervous system

BOSTON, Jan. 16, 2019 /PRNewswire/ -- CereVasc, LLC, a company focused on improving the care of patients with communicating hydrocephalus announced today the addition of acclaimed neuroscientist and author Lisa Genova, Ph.D., to the Board of Directors.

Key Points: 
  • BOSTON, Jan. 16, 2019 /PRNewswire/ -- CereVasc, LLC, a company focused on improving the care of patients with communicating hydrocephalus announced today the addition of acclaimed neuroscientist and author Lisa Genova, Ph.D., to the Board of Directors.
  • Dr. Genova is the New York Times bestselling author of several novels inspired by neuroscience and the human spirit.
  • "I look forward to working with CereVasc in advancing their technology as we strive to treat a variety of brain disorders."
  • Lisa was named one of the U.S. Top 50 Influencers in Aging by Next Avenue.