• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » BrainScope completes large-scale BrainScope One mTBI validation study

BrainScope completes large-scale BrainScope One mTBI validation study

March 28, 2019 By Fink Densford

Brainscope

BrainScope said today that it completed a validation study of its BrainScope One device designed to assess head injuries, exploring its ability to assess mild traumatic brain injuries in adolescent and young adult populations.

The Bethesda, Md.-based company ‘s FDA-cleared BrainScope One device is a multi-modal device designed to aid in the objective and rapid assessment and triage of head injury patients, and can assess the “full spectrum of brain injury” including concussions and brain bleeds.

BrainScope said that the study included data from nearly 1,700 subjects and more than 4,000 evaluations performed between 2015 and 2019. In the study, researchers aimed to create and validate an objective, personalized capability to assess concussions and readiness to return to activities in males and females between the ages of 13 and 25.

“These large studies add important information to the understanding of the pathophysiology of concussion, leading to better assessment capabilities which can improve short and long-term outcomes of head-injured patients,” chief scientific officer Leslie Prichep said in a prepared statement.

The company said that it released preliminary results related to concussion assessment capabilities for potential severity and the likelihood of prolonged recovery in the journal Computers in Biology and Medicine in January. Results from the study indicated highly significant differences in the BrainScope EEG-based biomarker at the time of injury between 177 concussed patients and controls with no significant differences at when Return-to-Play was clinically determined.

BrainScope added that progressive recovery over time was also objectively demonstrated, and that results supported the hypothesis that some of the more severely injured subjects may have been allowed to return to play too soon.

“We are extremely pleased to have concluded these substantial clinical studies over 4 years, the results of which are extremely exciting as we work in the near-term through appropriate regulatory processes to bring important new concussion assessment capabilities to the market. In particular I want to thank the U.S. Department of Defense, the NFL, GE, and BrainScope investors for their financial support of this major initiative which has yielded such excellent results,” CEO Michael Singer said in a press release

The company said that $9.9 million in funding for the study came from the U.S. Department of Defense. The trial was also supported by private funding and by funds from the NFL-GE Head Health Challenge.

In January, BrainScope said that it won FDA clearance to include a new indication language for its BrainScope One concussion assessment device.

Filed Under: Clinical Trials, Featured, Neurological Tagged With: BrainScope

In case you missed it

  • ZimVie sales down more than 11% in Q2 as it streamlines after spinoff
  • Data supports use of Channel Medsystems Cerene cryotherapy
  • The 10 largest orthopedic device companies in the world
  • Nanopath raises $10M Series A for women’s health diagnostics
  • Avenda wins FDA IDE nod for AI-enabled prostate cancer therapy
  • NuVasive chief commercial officer Massimo Calafiore is stepping down
  • Preparing your medical device company for challenging market conditions
  • Dentsply Sirona replaces chief accounting officer amid internal investigation
  • Haemonetics stock rises on Street-beating Q1, raised guidance
  • Surgalign settles on OEM business sale, posts Q2 earnings miss
  • Alcon lowers its 2022 forecast amid strong dollar
  • Masimo beats Street in Q2 as healthcare business catches up
  • Senseonics stock is up as it sticks by revenue guidance
  • Butterfly Network asks judge to dismiss Fujifilm Sonosite IP suit
  • Stereotaxis stock down amid cloudy outlook
  • BD, Labcorp collaborate on flow cytometry-based diagnostics
  • NeuroOne submits special FDA 510(k) application for Evo sEEG electrode

RSS From Medical Design & Outsourcing

  • COVID-19 immunity test developers at MIT seek diagnostic manufacturer
    MIT researchers have developed a device for predicting an individual’s COVID-19 immunity and are looking for a diagnostic company to get it manufactured in large numbers and approved by the FDA. The lateral flow test uses the same technology as at-home rapid antigen COVID-19 tests to measure neutralizing antibodies for SARS-CoV-2 in a blood sample,… […]
  • GE Healthcare picks AI imaging startups for inaugural Edison Accelerator
    GE Healthcare and Nex Cubed have selected seven companies focused on artificial-intelligence-augmented medical imaging for the first cohort of the Edison Accelerator in Canada. The companies will be matched with mentors and test their technologies with GE’s new Edison Digital Health Platform over the next three months. The program will end with innovation showcase presentations… […]
  • Boston Scientific whistleblower launches corruption investigation
    Boston Scientific (NYSE:BSX) is investigating claims that the company violated the U.S. Foreign Corrupt Practices Act in Vietnam. Marlborough, Massachusetts–based Boston Scientific disclosed receipt of a whistleblower’s allegations in its latest filing with the Securities and Exchange Commission. “In March 2022, the company received a whistleblower letter alleging Foreign Corrupt Practices Act violations in Vietnam.… […]
  • 5 essential leadership lessons from Cathy Burzik for medtech’s next generation of women leaders
    Cathy Burzik, a seasoned senior executive in the healthcare industry, has successfully led major medical device, diagnostic, diagnostic imaging and life sciences businesses. Cathy Burzik, CFB Interests (as told to MedExecWomen co-founder Maria Shepherd) One key to being a successful women leader in MedTech: “Play nice, but play to win.” Cathy Burzik, who received a… […]
  • Stratasys plans to buy Covestro’s additive manufacturing business
    Stratasys (Nasdaq:SSYS) said today that it has a deal to purchase the additive manufacturing materials business of Covestro. The deal includes R&D facilities and activities, global development and sales teams across Europe, the U.S. and China, a portfolio of approximately 60 additive manufacturing materials, and hundreds of patents and patents pending, Stratasys said in a… […]
  • New implant design prevents scar tissue without drugs, MIT says
    Mechanically inflating and deflating an implantable device for 10 minutes a day prevents immune cells from building the scar tissue that has been a major obstacle for artificial pancreas researchers. That’s according to new findings from a team of MIT engineers who built mechanical deflection into a two-chambered, soft polyurethane device tested on mice. By… […]
  • Blue Spark’s TempTraq catches fevers faster. Fever prediction is next.
    Blue Spark Technologies developed the first wireless continuous temperature monitor patch, TempTraq, to enable faster fever detection than standard manual readings every four hours. Westlake, Ohio-based Blue Spark is now looking at fever prediction rather than just detecting them. The R&D team is working on developing an AI neural network model built on the company’s… […]
  • Harvard researchers plan to sell at-home, PCR-grade COVID testing system
    The Harvard University researchers who developed an ultrasensitive, PCR-grade nucleic acid detection technology plan to commercialize it as a portable COVID-19 test. Harvard Medical School professor Peng Yin, who also leads the Wyss Institute for Biologically Inspired Engineering’s Molecular Robotics Initiative, founded 3EO Health to sell the device. “In order to optimize the value of… […]
  • FDA reports sterilization challenge progress as EPA takes aim at EtO emissions
    The FDA offered an update on its efforts to make medical device sterilization safer as the EPA identified 23 U.S. facilities where use of ethylene oxide (EtO) presents a risk to communities. The FDA said it is similarly concerned about unsafe EtO emissions and highlighted work with the medical device industry to reduce EtO usage… […]
  • AdvaMed defends EtO facilities on EPA’s cancer risk list
    The Advanced Medical Technology Association (AdvaMed) today reacted to the EPA’s listing of commercial sterilization facilities causing elevated risks of cancer with a defense of the facilities and a call for more research. AdvaMed CEO and President Scott Whitaker said all of the listed facilities are in compliance with regulations and warned against closures. “The… […]
  • EPA flags high-cancer-risk EtO sterilization facilities across the country
    The EPA today identified nearly two dozen U.S. cities where commercial sterilizers using ethylene oxide (EtO) contribute to an elevated cancer risk for residents of surrounding communities. EtO is used on about 20 billion medical devices each year — or about half of all sterile medical devices —  and in some cases it’s the only… […]

Primary Sidebar

DeviceTalks Weekly

August 5, 2022
DTW Medtronic's Greg Smith lays out supply chain strategies
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy