• 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
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates
Home » Abbott gains FDA clearance for rapid concussion test

Abbott gains FDA clearance for rapid concussion test

January 11, 2021 By Sean Whooley

AbbottAbbott (NYSE:ABT) announced today that it received FDA 510(k) clearance for its rapid handheld traumatic brain injury (TBI) blood test.

According to a news release, the test is designed to help clinicians assess individuals with suspected mild TBIs, including concussions.

The test runs on Abbott’s handheld i-STAT Alinity platform, with results provided within 15 minutes after the plasma is placed in the test cartridge. A negative test can be used to rule out the need for a head CT scan, while a positive test complements CT scans to help a clinician’s evaluation, the company said.

Abbott’s test requires a small blood sample drawn from the arm, from which plasma is extracted with a centrifuge, then applied to the test’s cartridge before the cartridge is inserted into the i-STAT Alinity instrument.

“Healthcare providers have been waiting for a blood test for the brain and now we have one,” Abbott diagnostic business medical director Dr. Beth McQuiston said in the release. “You can’t treat what you don’t know and now physicians will be equipped with critical, objective information that will help them provide the best care possible, allowing patients to take steps to recover, prevent reinjury and get back to doing the things they care about most.”

The company said it is also working on a whole blood test that would eliminate the need for separating plasma and provide an option at the patient’s side in a healthcare setting. Abbott is envisioning a portable test with the same result turnaround time that can be used outside a traditional healthcare setting to evaluate head injuries quickly, like at sporting events.

Abbott also received FDA breakthrough device designation for a TBI test to run on its Alinity i and Architect core laboratory instruments to widen the range of settings in which its diagnostics are available.

Filed Under: 510(k), Diagnostics, Featured, Food & Drug Administration (FDA), Neurological, Regulatory/Compliance Tagged With: Abbott, FDA

In case you missed it

  • Organ-chips could streamline drug development, but hurdles remain
  • Ivermectin not supported for mild COVID-19, study says
  • ControlRad gains clearance for imaging tech to sell to Boston Sci
  • Capsule lands Frost & Sullivan award for remote ventilator monitor
  • Philips debuts AI-enhanced imaging platform
  • Pulmatrix completes $40M offering, updates product pipeline timetable
  • Medtronic launches IDE trial for AFib tech
  • Medtronic hiring Walmart exec to run its supply chain
  • An Overview of IEC 60601-1 3rd Edition, 2nd Amendment
  • Report: Permira eyeing LivaNova purchase
  • Amgen to acquire Five Prime Therapeutics for $1.9B
  • Medtronic wins city council approval for 42-acre campus in Colorado
  • Conformis dips 9% on Street-beating Q4 results
  • Becton Dickinson acquires smart medication device maker GSL Solutions
  • FDA clears once-daily ADHD capsule from Corium
  • Philips and Disney want to make MRIs easier for children: Here’s how
  • Origami Surgical gains FDA clearance for robotic suturing devices

RSS From Medical Design & Outsourcing

  • Medtronic hiring Walmart exec to run its supply chain
    Medtronic (NYSE:MDT) CEO Geoff Martha announced that the company is appointing Greg Smith as EVP of global operations and supply chain. In a LinkedIn post today, Martha wrote: “I’m pleased to share that Greg Smith, Executive Vice President of U.S. Supply Chain for Walmart, is joining Medtronic on April 5 as Executive Vice President of… […]
  • Philips and Disney want to make MRIs easier for children: Here’s how
    Royal Philips (NYSE:PHG) announced today that it is teaming up with Disney to test the effects of custom-made animation to create a relaxing atmosphere for young patients. Amsterdam-based Philips will collaborate with The Walt Disney Company EMEA to see whether the animation, including specially-made Disney stories within Philips’ Ambient Experience, creates a relaxing atmosphere to improve… […]
  • Origami Surgical gains FDA clearance for robotic suturing devices
    Origami Surgical today announced that the FDA has granted 510(k) clearance for three new types of sutures for its StitchKit robotic surgery platform. The company describes StitchKit as a patented suture delivery and retrieval system designed so sutures are efficiently inserted and needles are safely removed from the surgical field. StitchKit also allows the robotic… […]
  • NAMSA acquires American Preclinical
    Contract research organization NAMSA today announced its acquisition of Minneapolis-based American Preclinical Services (APS). This purchase follows NAMSA’s acquisition of New York-based Syntactx, a clinical research services CRO, in January. The acquisition will provide NAMSA customers with a broader range of laboratory models and analysis tools, including innovative surgical instrumentation and several state-of-the-art catheterization labs,… […]
  • 5 reasons Medtronic’s CEO is optimistic about the future
    Nearly a year after Geoff Martha took over the corner office at Medtronic, the world’s largest medical device company is transforming. In a recent interview with our DeviceTalks Weekly podcast, Martha detailed Medtronic‘s major reorganization, its shift in corporate culture and more. Martha was also highly pleased about Medtronic’s recent Q3 earnings results. Here are… […]
  • Medtronic is changing a lot: Here’s what you need to know
    CEO Geoff Martha says Medtronic‘s ongoing corporate restructuring will position the company to compete better with medical device rivals, freeing the front-line forces from earlier entanglements. But the change will also create new opportunities for Medtronic employees at the company and elsewhere. In a far-ranging interview with the DeviceTalks Weekly podcast, Martha reviewed the company’s… […]
  • Pharma’s been slow to adopt Industry 4.0 — but that could change
    The pharma industry has been relatively slow to embrace concepts such as Industry 4.0, but COVID-19 is serving as a catalyst for sweeping changes within the industry. The philosophy has roots in a German framework that prioritizes digitization to drive manufacturing efficiency, promising that cyber-physical systems will usher in the next industrial revolution. The Industry… […]
  • Ambu single-use endoscope wins Frost & Sullivan innovation award
    Frost & Sullivan today announced that it awarded Ambu with a 2021 Global New Product Innovation Award. Ambu received the award for its single-use flexible endoscopes that are designed to make the devices safe, affordable and accessible. It has aView and aBox all-in-one video displays that eliminate the traditional video endoscopy tower size and expense to be… […]
  • Could this hydrogel repair a broken heart?
    European researchers have developed an injectable hydrogel that could help repair and prevent further heart muscle damage after a heart attack. The therapeutic effect of multiple injections of this hydrogel into the cardiac tissue was assessed during the first preclinical study of its kind, demonstrating its efficacy for cardiac tissue remodeling following a heart attack,… […]
  • How EtO plants can avoid lawsuits, cope with stricter regulation
    If EtO industry actors take certain targeted steps now, they can minimize legal exposure, more efficiently manage litigation and be better situated for compliance once new federal regulations are established. Karen Cullinane, Goldberg Segalla The use of ethylene oxide (EtO) to sterilize medical devices came under renewed scrutiny after the Environmental Protection Agency concluded in… […]
  • FDA authorizes Q-Collar to help protect athletes’ brains
    The FDA announced today that it authorized the Q-Collar made by Q30 Sports Science for protecting the brain during sports activities. Q30 Sports Science’s Q-Collar is a C-shaped collar worn around the neck designed to apply compressive force to the neck and increase blood volume to help reduce movement of the brain within the cranial… […]

Primary Sidebar

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.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · 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 | RSS