Intracranial pressure

Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP

Retrieved on: 
Friday, February 23, 2024
Fever, European Commission, EMA, ALS, Committee, MND, Myalgia, Intracranial pressure, BIIB, Cerebrospinal fluid, Pain, Hope, Biogen, European, SOD1, Arthralgia, Civil service commission, Biomarker, Fatigue, CHMP, AFL, European Medicines Agency, Protein, Disease, UZ Leuven, Mutation, Myelitis, Neurology, Aseptic meningitis, Research, Chronic pain, Vaccine

If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).

Key Points: 
  • If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).
  • “The CHMP’s positive opinion reinforces the impact QALSODY can have in SOD1-ALS and further demonstrates Biogen’s commitment to address the unmet needs of people living with ALS and neuromuscular diseases,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen.
  • Trends towards improvement in the physical abilities of participants who received QALSODY were seen compared to those who received placebo, as measured by the ALS Functional Ratings Scale-Revised (ALSFRS-R).
  • Serious neurologic events, including myelitis and/or radiculitis; papilledema and elevated intracranial pressure; and aseptic meningitis have also been reported.

Global Intracranial Pressure Monitoring Devices Market Forecast Report to 2028, Featuring Integra LifeSciences, Medtronic, IRRAS, RAUMEDIC, Vivonics, Brain4Care, Luciole Medical& TKB - ResearchAndMarkets.com

Retrieved on: 
Wednesday, January 24, 2024
Health, Medical Devices, Hospitals, Surgery, Other Science, General Health, Science, Sleep, Brain damage, Patient, TBI, Hospital, Trauma, Infection, Research, Incidence, Cloud computing, Intraparenchymal hemorrhage, Application, ICP, Accident, Developed country, DSM-IV codes, AI, Government, Public, Intracranial pressure, Safety, COVID-19, Medicine, Bleeding, Organization, Data analysis, Ageing, Diagnosis, Prevalence, Medical device

The global Intracranial pressure (ICP) monitoring device market value stood at US$1.68 billion in 2022, and is expected to reach US$2.52 billion by 2028.

Key Points: 
  • The global Intracranial pressure (ICP) monitoring device market value stood at US$1.68 billion in 2022, and is expected to reach US$2.52 billion by 2028.
  • The global intracranial pressure monitoring market is moderately fragmented, with increasing number of large and medium sized players striving to gain a significant market share.
  • New and inexpensive products are being introduced by top companies in the intracranial pressure monitoring devices market to flourish in unexplored regions & help the industry expand.
  • The key players of the global intracranial pressure monitoring market are:

RevBio Receives FDA Approval to Conduct a First-in-Human Clinical Trial for its Regenerative Bone Adhesive for Cranial Flap Fixation

Retrieved on: 
Friday, December 8, 2023
Research, Surgery, Medical Devices, Medical Supplies, FDA, Clinical Trials, Biotechnology, Health, Science, Subdural empyema, Safety, Food, Crystal skull, Risk, Aneurysm, CSF, Clinical trial, Multimedia, Skull, Infection, Osteoblast, MPH, Pain, Intracranial pressure, Cerebrospinal fluid, Meningitis, Architecture, Boston, MD, Brigham, Doctor of Philosophy

This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company.

Key Points: 
  • This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company.
  • As part of the surgical closure process, the cranial flap is secured back into place with plates and screws.
  • The kerf line, however, is typically not sealed, which compromises the ability of the flap to integrate with the surrounding bone.
  • “We are truly excited to move this project into the clinical phase of testing,” said Brian Hess, CEO and Founder of RevBio.

Injectsense and Solid-State Microbattery Partner Injectpower Secure $9.4M for Implantable Device Supply Chain and Support of Clinical Studies

Retrieved on: 
Wednesday, November 15, 2023
Sleep, Pressure, Intraocular pressure, Safety, Pathology, Learning, IOP, Data analysis, Grain, Wilmer Ophthalmological Institute, ICP, NIH, Software, Lithium, Intracranial pressure, Paratriathlon, Johns Hopkins University, Glaucoma, Medical imaging, Medical device

Injectsense sensors measure IOP continuously, even during sleep, when pressure can spike significantly and cause vision loss over the long term.

Key Points: 
  • Injectsense sensors measure IOP continuously, even during sleep, when pressure can spike significantly and cause vision loss over the long term.
  • The cluster will streamline business opportunities, enable improved supply chain management, and support Injectsense's February 2024 first-in-human studies for sensors that continuously measure intraocular pressure (IOP).
  • The study will allow Injectsense to finalize its product development under its quality system for ramp-up to clinical studies in 2025.
  • The first components have already been developed, characterized and tested on a pre-commercial 200mm microelectronic supply chain with support from CEA/LETI, for Injectsense.

CereVasc eShunt® System Study Data Presented at the European Society of Minimally Invasive Neurological Therapy (ESMINT) Congress in Marseille

Retrieved on: 
Wednesday, September 13, 2023
Hydrocephalus, Sagrada Família, DSM-IV codes, Trial of the century, Congress, Subarachnoid hemorrhage, CH, Patient, Intracranial pressure, Pharmaceutical industry, Medical device

Trial data reporting the investigational use of the eShunt System in patients with hydrocephalus secondary to subarachnoid hemorrhage was presented by Ivan Lylyk, M.D., one of the lead investigators based at Clínica La Sagrada Familia in Buenos Aires, Argentina.

Key Points: 
  • Trial data reporting the investigational use of the eShunt System in patients with hydrocephalus secondary to subarachnoid hemorrhage was presented by Ivan Lylyk, M.D., one of the lead investigators based at Clínica La Sagrada Familia in Buenos Aires, Argentina.
  • The study, conducted under the leadership of Pedro Lylyk, M.D., represents the first-ever treatment with the eShunt System and the world's first endovascular treatment of CH.
  • "We are excited by the initial data demonstrating the potential to provide patients a minimally invasive treatment for communicating hydrocephalus.
  • The data presented at ESMINT bolster our confidence in the potential of the Company's minimally invasive treatment of hydrocephalus as we transition to the pivotal clinical trial in early 2024."

Nature-inspired pressure sensing technology aims to transform healthcare and surgical robots

Retrieved on: 
Friday, August 18, 2023
Tissue, Pressure, Surgeon, Engineering, National University of Singapore, National university, Prognosis, Yale-NUS College, Associate, Lotus, Nature Materials, System, ICP, NUS, Intracranial pressure, Medical imaging

SINGAPORE, Aug. 18, 2023 /PRNewswire/ -- Researchers at the National University of Singapore (NUS) have developed a novel aero-elastic pressure sensor, called 'eAir'. This technology can be applied to minimally-invasive surgeries and implantable sensors by directly addressing the challenges associated with existing pressure sensors.

Key Points: 
  • This technology can be applied to minimally-invasive surgeries and implantable sensors by directly addressing the challenges associated with existing pressure sensors.
  • It can potentially transform laparoscopic surgeries by enabling tactile feedback for surgeons, allowing more precise manipulation of patient tissues.
  • In addition, the sensor can improve patient experiences by offering a less invasive means of monitoring intracranial pressure (ICP).
  • Mimicking this effect, the team has engineered a pressure sensor designed to significantly improve the sensing performance.

Nature-inspired pressure sensing technology aims to transform healthcare and surgical robots

Retrieved on: 
Friday, August 18, 2023
Tissue, Medical school, Pressure, Science, Surgeon, Headache, Atmosphere, Engineering, Intuition, National University of Singapore, Consultant, National university, National University Hospital, Perception, Prognosis, Skull, Multimedia, Brain damage, General surgery, Yale-NUS College, Associate, Movement, Lotus, Patent, Nature Materials, Ng Teng Fong General Hospital, Hospital, System, ICP, NUS, Intracranial pressure, Medical imaging, Instrumentation, 3D printing, Medicine

SINGAPORE, Aug. 18, 2023 /PRNewswire/ -- Researchers at the National University of Singapore (NUS) have developed a novel aero-elastic pressure sensor, called 'eAir'. This technology can be applied to minimally-invasive surgeries and implantable sensors by directly addressing the challenges associated with existing pressure sensors.

Key Points: 
  • This technology can be applied to minimally-invasive surgeries and implantable sensors by directly addressing the challenges associated with existing pressure sensors.
  • It can potentially transform laparoscopic surgeries by enabling tactile feedback for surgeons, allowing more precise manipulation of patient tissues.
  • Mimicking this effect, the team has engineered a pressure sensor designed to significantly improve the sensing performance.
  • At the same time, they have filed a patent for the eAir sensor technology in Singapore, and aims to translate the technology for real-world applications.

Rising Pharmaceuticals Launches Edetate Calcium Disodium Injection, an Important Antidote Treatment to Address Lead Poisoning.

Retrieved on: 
Thursday, August 10, 2023
Other Health, Men, General Health, Pharmaceutical, Family, Consumer, Hospitals, Children, Other Consumer, Women, FDA, Health, Hepatitis, Lead poisoning, Urine, Cerebral edema, Lead, Stock, CMO, CDO, Medication, Patient, Mortality, Intracranial pressure, Anuria, Pharmaceutical industry, Ethylenediaminetetraacetic acid

Rising Pharmaceuticals, an affiliate of Rising Pharma Holdings Inc., announced the approval, launch and immediate commercial availability of Edetate calcium disodium injection.

Key Points: 
  • Rising Pharmaceuticals, an affiliate of Rising Pharma Holdings Inc., announced the approval, launch and immediate commercial availability of Edetate calcium disodium injection.
  • This launch will address a critical commercial shortage of this important therapy in the United States.
  • Rising’s Edetate calcium disodium injection is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults.
  • “The approval and launch of Rising’s Edetate calcium disodium injection opens access to a critical treatment option for patients exposed to lead poisoning, and further demonstrates Rising’s commitment to addressing product supply shortages for the patients who need them,” said Ira Baeringer, Chief Operating Officer, Rising Pharmaceuticals.

Anuncia Medical Announces the First Successful US Implant of the Company's Newly Commercially Released ReFlow™ Mini Flusher Device for Hydrocephalus Patients

Retrieved on: 
Tuesday, August 1, 2023
Depression, University, Sales & Marketing Executives International, Brain, Neurosurgery, Brain damage, Cell, Scalp, Intermountain, Soldering, Hydrocephalus, MD, Patient, Frustration, CSF, Hospital, FDA, Death, ICP, Intracranial pressure, Medical device, Medical imaging

SCOTTSDALE, Ariz., Aug. 1, 2023 /PRNewswire/ -- Anuncia Medical Inc. ("Anuncia" or the "Company"), a Company specializing in advancing innovations for implantable and external cerebrospinal fluid (CSF) management systems and neurocritical care, is pleased to announce the successful first implant of the Company's FDA-cleared ReFlow™ Mini Flusher device.

Key Points: 
  • The second-generation, FDA-cleared ReFlow Mini Flusher is indicated for use in patients living with hydrocephalus or similar conditions.
  • The reduced size and profile of the technology is designed to better support a broader hydrocephalus patient population, from infants to older adults.
  • The first-generation ReFlow device was successfully implanted in over 30 patients with hydrocephalus and is the subject of 11 clinical studies/reports.
  • It is expected that the ReFlow Mini Flusher will be available internationally in the future.

EQS-News: Healthcare specialist SHS Capital sells Spiegelberg, a leading medtech expert for devices and consumables in the field of neurosurgery, to Luciole Medical

Retrieved on: 
Tuesday, June 27, 2023
Growth, SHS, EVD, Hospital, Acquisition, Neurosurgery, ICP, Brain, Catheter, Intracranial pressure, Jugular vein, Medical imaging, Management, Health care, Spiegelberg

Healthcare specialist SHS Capital sells Spiegelberg, a leading medtech expert for devices and consumables in the field of neurosurgery, to Luciole Medical

Key Points: 
  • Healthcare specialist SHS Capital sells Spiegelberg, a leading medtech expert for devices and consumables in the field of neurosurgery, to Luciole Medical
    The issuer is solely responsible for the content of this announcement.
  • Luciole Medical AG, which specialises in cerebral monitoring and measurement of oxygen saturation in the brain, is expanding its product range with the acquisition of Spiegelberg
    German healthcare specialist SHS Capital is selling its shares in Spiegelberg to Luciole Medical AG.
  • Spiegelberg, a medical technology company based in Hamburg, develops, produces and distributes highly specialised catheters and measuring probes for neurosurgical applications in the brain.
  • Founded in 1986, Spiegelberg has developed into a recognised provider in the field of intracranial pressure measurement.