Epidural hematoma

New Research Shows Minimally Invasive Therapy (Middle Meningeal Artery Embolization) is Effective in Treating Chronic Subdural Hematoma

Retrieved on: 
Monday, February 12, 2024
Subdural space, Recurrence, Doctor of Philosophy, Neurosurgery, Blood, Arm, STEM, FDA, U.S. FDA, Skull, Leg, BALT, Society, University, Disease, Stony Brook University, MMAE, Patient, MPH, Epidural hematoma, Mortality, Research, Brain, Birth control

FAIRFAX, Va., Feb. 12, 2024 /PRNewswire/ -- The Society of Neurolnterventional Surgery (SNIS) is acknowledging middle meningeal artery embolization (MMAE) as a beneficial adjunctive treatment for chronic subdural hematoma in light of new research. The minimally invasive MMAE procedure significantly reduced the failure rates of traditional surgical and non-surgical management strategies without an increased rate of serious neurological complications.

Key Points: 
  • Chronic subdural hematoma refers to the gradual accumulation of blood over the surface of the brain.
  • As the U.S. population continues to age, studies show that chronic subdural hematomas may be the most prevalent neurosurgical diagnosis that requires treatment within the next decade.
  • However, an average of 10% to 30% of patients experience recurrence of chronic subdural hematoma after surgery, often necessitating reoperation.
  • Chronic subdural hematoma is an exceedingly common problem, and these findings will be relevant to a large population of patients.

New Late Breaking Preliminary Data Demonstrate Balt’s Squid™ Liquid Embolic May Improve Outcomes in Patients with Chronic Subdural Hematomas

Retrieved on: 
Friday, February 9, 2024
Randomized controlled trial, Balts, Veterans' affairs, Embolization, FDA, Prevalence, STEM, Disability, Conference, University, SDH, Physician, MPH, United, MMA, IDE, Incidence, Epidural hematoma, Patient, Person, Stony Brook University Hospital, Ageing, Disease, Doctor of Philosophy, Death, Pharmaceutical industry

The preliminary data demonstrates that rates of complications thus far are low and embolizing the MMA for the treatment of Chronic Subdural Hematoma (cSDH) potentially improves the success rates of both surgical and non-surgical treatments.

Key Points: 
  • The preliminary data demonstrates that rates of complications thus far are low and embolizing the MMA for the treatment of Chronic Subdural Hematoma (cSDH) potentially improves the success rates of both surgical and non-surgical treatments.
  • Standard management included surgical drainage of the subdural hemorrhage for qualified patients and best medical management for patients who did not require surgery.
  • STEM, which completed enrollment last year, is the first prospective IDE trial investigating embolization of the MMA for the treatment of chronic Sub-Dural Hematoma (cSDH).
  • A Veterans Affairs (VA) study of cSDH found a prevalence rate of 79.4 per 100,000 persons.

RapidAI Receives FDA Clearance of AI Module for Detection of Hemispheric Subdural Hematomas

Retrieved on: 
Thursday, November 9, 2023
Apps, Applications, Technology, Surgery, FDA, Health Technology, Cardiology, Software, General Health, Health, Artificial Intelligence, Stroke, Intelligence, ICH, Rapids, PACS, Mortality, Trauma, Bleeding, Artificial intelligence, Traumatic brain injury, Epidural hematoma, AI, Patient, SDH, Medical device, Nursing

RapidAI , the global leader in developing Artificial Intelligence (AI) and technology workflow solutions to combat life-threatening neurovascular, trauma, cardiac and vascular conditions, today announced it has received FDA clearance for Rapid SDH, its AI-powered module for the detection and notification of suspected hemispheric acute and chronic subdural hematoma.

Key Points: 
  • RapidAI , the global leader in developing Artificial Intelligence (AI) and technology workflow solutions to combat life-threatening neurovascular, trauma, cardiac and vascular conditions, today announced it has received FDA clearance for Rapid SDH, its AI-powered module for the detection and notification of suspected hemispheric acute and chronic subdural hematoma.
  • Together with Rapid ICH and Rapid Hyperdensity , the three modules comprise RapidAI’s unique and industry-best hemorrhagic and trauma care AI solution, designed to help teams on the front lines of patient assessment streamline decision making and expedite patient care.
  • The need for the RapidAI solution is urgent, with SDH cases in US patients expected to increase by nearly 80% before 2040 and current estimated mortality rates at 40-60% – underscored by neurosurgical workforce shortages across the country.
  • Rapid SDH leverages AI and the intelligence gained from analyzing hundreds of patient scans to help neurocritical care teams identify suspected hemispheric subdural hemorrhage faster and with a higher degree of accuracy than traditional methods.

Aidoc Introduces the First and Only AI-Powered Solution to Identify Suspected Posterior and Anterior Large and Medium Vessel Occlusions

Retrieved on: 
Monday, July 31, 2023
Neuroradiology, Society, University, Prevalence, Workflow, Stroke, Anatomy, Epidural hematoma, Intelligence, Associate, Organization, Patient, Standard of care, EHR, Intracerebral hemorrhage, AI, Health, Aidoc, Health information management, LVO, Medical device, Mevo

NEW YORK, July 31, 2023 /PRNewswire/ -- Aidoc, a pioneering force in clinical AI, announced today the launch of its revolutionary Full Brain Solution. This new solution will significantly expand the anatomy analyzed by AI to identify suspected strokes, allowing for identification and care coordination of patients with medium vessel occlusions (MeVOs) as well as posterior and anterior large vessel occlusions (LVOs).

Key Points: 
  • NEW YORK, July 31, 2023 /PRNewswire/ -- Aidoc, a pioneering force in clinical AI, announced today the launch of its revolutionary Full Brain Solution.
  • This new solution will significantly expand the anatomy analyzed by AI to identify suspected strokes, allowing for identification and care coordination of patients with medium vessel occlusions (MeVOs) as well as posterior and anterior large vessel occlusions (LVOs).
  • The Full Brain Solution represents a significant advancement in medical technology aiding patient care, being the first and only AI technology to identify suspected posterior and anterior LVOs and MeVOs.
  • The prevalence of the newly covered conditions, posterior LVO and MeVO, is significant.

New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Retrieved on: 
Monday, June 26, 2023
EOS, HDFN, Fetus, Umbilical cord, European Medicines Agency, Janssen, Janssen Pharmaceuticals, Patient, Memorial Hermann–Texas Medical Center, Risk, Immunoglobulin G, Disease, Infant, IUT, Neonatal Fc receptor, UNITY, Tissue, Ohio State University, Hydrops, University, Dell Medical School, Gestational age, EMA, SPRING, Diagnosis, FDA, FC, Placenta, HOUSE, Health, Maternal–fetal medicine, Child, Șaeș, Blood, Immune system, Mortality, Johnson & Johnson, Epidural hematoma, Anemia, Infection, Edema, Clinical trial, Fast Track, Mount Sinai Hospital, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Birth control, Dietary supplement

SPRING HOUSE, Pa., June 26, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) hemolytic disease of the fetus and newborn (HDFN).1 A statistically significant (54 percent [n=7/13]) proportion of participants who received nipocalimab achieved the primary endpoint of a live birth at or after gestational age of 32 weeks without intrauterine transfusions (IUTs)1,a compared to the historic reference point of 10 percent, which was derived from published and unpublished data.2-5,b Among the seven participants who achieved the primary endpoint, the median gestational age at delivery was 37 and 1/7 weeks.6 This study demonstrates the potential for nipocalimab to help address the underlying disease mechanism of EOS HDFN.1 If approved, nipocalimab would be the first anti-neonatal Fc receptor (FcRn) treatment and the first approved non-surgical intervention for pregnancies at high risk of HDFN in the U.S.7 These data will be presented for the first time at the Fetal Medicine Foundation World Congress in Valencia, Spain on June 26, 2023.1 Janssen is planning a pivotal Phase 3 trial for nipocalimab in pregnancies at risk for severe HDFN.

Key Points: 
  • "There is a significant unmet need to help address the serious and life-threatening health consequences of HDFN.
  • "These Phase 2 UNITY data in high-risk pregnancies demonstrated the important role that nipocalimab, an FcRn blocking antibody, may play in preventing the transfer of maternal alloantibodies through the placenta, thereby offering a potential treatment option for this devastating disease."
  • A conservative benchmark of 10 percent of patients not requiring an IUT was chosen to account for uncertainties in the accuracy and representation of the underlying data.2
    d.  Dr. Kenneth Moise is a paid consultant for Janssen.
  • He has not been compensated for any media work.

Gradient Health pens huge collaboration agreement with Cone Health to accelerate innovation.

Retrieved on: 
Thursday, January 12, 2023
Lung cancer, Medicine, Epidural hematoma, Gradient, Aneurysm, Cone Health, Patient, Intelligence, Medical imaging

RALEIGH, N.C., Jan. 12, 2023 /PRNewswire/ -- Medical technology company Gradient Health today announced a landmark collaboration with not-for-profit health system Cone Health, helping to accelerate innovation of medical imaging technologies.

Key Points: 
  • RALEIGH, N.C., Jan. 12, 2023 /PRNewswire/ -- Medical technology company Gradient Health today announced a landmark collaboration with not-for-profit health system Cone Health, helping to accelerate innovation of medical imaging technologies.
  • That's why Cone Health have ensured their patients don't get left behind by the latest advances in medical technology by securely sharing anonymized data with tomorrow's innovators.
  • Gradient Health, via their platform, provides leading medical researchers with access to the data they need to engineer more equitable and representative products for patients.
  • In providing secure access to anonymized data that otherwise would have sat on a hard drive, Cone Health and Gradient are helping to advance medical care for millions of people, with dozens of diseases.

Viz.ai Receives FDA 510(k) Clearance for Viz SDH

Retrieved on: 
Wednesday, July 27, 2022
Health, FDA, Medical Devices, Technology, Hospitals, Software, Artificial Intelligence, Subdural hematoma, Algorithm, Diagnosis, Intelligence, Physician, Health informatics, Food and Drug Administration, Chaman, Food, Doctor of Philosophy, Hospital, Associate, Informatics, Medicare, SUNY, SDH, EMEA, Triage, Epidural hematoma, Machine learning, Ageing, Viz, Cerebrovascular disease, Disease, FDA, MD, State university system, Patient, Forbes, Workflow, AI, State, Medical device, Neurosurgery, Buffalo, Health, FDA, Medical Devices, Technology, Hospitals, Software, Artificial Intelligence

Viz.ai , the leading AI-powered disease detection and intelligent care coordination platform, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz Subdural (SDH).

Key Points: 
  • Viz.ai , the leading AI-powered disease detection and intelligent care coordination platform, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz Subdural (SDH).
  • The Viz SDH algorithm uses artificial intelligence to automatically detect subdural hemorrhage, enabling physicians to triage patients effectively and deliver optimal care.
  • Viz SDH allows us to detect both acute and chronic subdural hemorrhages to better identify early treatment pathways.
  • The Viz SDH module is another of the fast-growing number of FDA cleared AI algorithms on the enterprise-wide Viz Platform, which is clinically validated and reimbursed by Medicare and proven to save time, improve patient outcomes and access to care.

Helicon Arts Cooperative Announces Feature Film "Contre-Coup," James Kerwin To Direct With Cast To Include Rekha Sharma and Nicola Bryant

Retrieved on: 
Monday, May 30, 2022
Family Plan, Star Trek Continues, Star Trek, Emblem3, Yesterday Was a Lie, Vampire, M-Phazes, Warner Bros., Biz, Epidural hematoma, Entertainment One, COVID-19, Train, Musical, Life, Writing, NOTD, Train Stop – Two Minutes, Battlestar Galactica, IndiePix Films, Discovery, Andy Hill (American music producer), Film, Universal, Helicon, Yellowjackets, The Walt Disney Company

LOS ANGELES, May 30, 2022 /PRNewswire/ -- The non-profit foundation Helicon Arts Cooperative announces a new reality-bending psychological mystery feature film, "Contre-Coup."

Key Points: 
  • LOS ANGELES, May 30, 2022 /PRNewswire/ -- The non-profit foundation Helicon Arts Cooperative announces a new reality-bending psychological mystery feature film, "Contre-Coup."
  • Attached is director James Kerwin, who is known for Entertainment One's cult sci-fi feature film "Yesterday Was a Lie" (which recently received a tenth anniversary re-release from IndiePix Films).
  • James is also known for writing and directing the acclaimed fan-favorite web series "Star Trek Continues."
  • Helicon Arts Cooperative is a non-profit cinematic arts foundation based in Los Angeles, California.

BeiGene Announces Approval for BRUKINSA (zanubrutinib) by Swissmedic for Treatment of Adult Patients with Waldenström’s Macroglobulinemia

Retrieved on: 
Thursday, February 17, 2022
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, American Oncology Institute, Tissue, Private Securities Litigation Reform Act, Adult, Goal, MAA, Therapy, Technology, Division, U.S. Securities and Exchange Commission, Liver, Population, Bristol Myers Squibb, Spleen, Pharmacokinetics, ITT, COVID-19, Federal, Form 10-Q, Half-life, Company, BTK, MYD88, Lancet, Public health, Hematology, Twitter, Food, Tislelizumab, Research, BLA, Cardiomegaly, NASDAQ, ASPEN, Diarrhea, Drug, Incidence, Review, B-cell lymphoma, Safety, Jazz Pharmaceuticals, Marketing, Disease, Lymph, PARP, IRC, Intellectual property, Patient, WM, Man, Federal Office of Public Health, Global health, Lymphoid leukemia, SSE, Novartis, FDA, Epidural hematoma, Bone marrow, Neutropenia, Pharmaceutical industry, Swissmedic, BeiGene, EU, Waldenström’s Macroglobulinemia, BRUKINSA, BeiGene, WALDENSTRöM’S MACROGLOBULINEMIA, BRUKINSA, BEIGENE

BRUKINSA is a next-generation BTK inhibitor which has also provided meaningful improvements in tolerability for some patients with WM compared to ibrutinib, as treatment discontinuation remains a concern.

Key Points: 
  • BRUKINSA is a next-generation BTK inhibitor which has also provided meaningful improvements in tolerability for some patients with WM compared to ibrutinib, as treatment discontinuation remains a concern.
  • Our teams are committed to collaborating with the Federal Office of Public Health and healthcare professionals to ensure access to BRUKINSA for patients in Switzerland.
  • BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide.
  • Treatment and outcome patterns in European patients with Waldenstrms macroglobulinaemia: a large, observational, retrospective chart review.

MCRA Expands Neurology Division into Neurointerventional Market

Retrieved on: 
Wednesday, September 22, 2021
Elective surgery, Stroke, Contract research organization, Quality assurance, Dural arteriovenous fistula, VB, FDA, Patient, Engineering, Intracranial aneurysm, Neurosurgery, IVD, Hydrocephalus, Food and Drug Administration, General surgery, Computer security, LLC, Neurology, MCRA, Idiopathic intracranial hypertension, Trial of the century, Journal of NeuroInterventional Surgery, DC, Boston Scientific, Technology, Research, Epidural hematoma, CRO, Robotics, Spine, Industry, Google Images, Medical device

Herrmann also had significant interactions onapplications for the clinical use ofdrug and biologic baseddevice combination products during his time with the agency.

Key Points: 
  • Herrmann also had significant interactions onapplications for the clinical use ofdrug and biologic baseddevice combination products during his time with the agency.
  • Dr. Herrmann said "I am very excited to join the highly distinguished team at MCRA and expand their regulatory expertise in the area of neurointerventional devices.
  • About MCRA, LLC:MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm.
  • MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and serves more than 700 clients globally.