• HOME
  • NEWS
  • EXPLORE
    • CAREER
      • Companies
      • Jobs
    • EVENTS
    • iGEM
      • News
      • Team
    • PHOTOS
    • VIDEO
    • WIKI
  • BLOG
  • COMMUNITY
    • FACEBOOK
    • INSTAGRAM
    • TWITTER
Saturday, October 4, 2025
BIOENGINEER.ORG
No Result
View All Result
  • Login
  • HOME
  • NEWS
  • EXPLORE
    • CAREER
      • Companies
      • Jobs
        • Lecturer
        • PhD Studentship
        • Postdoc
        • Research Assistant
    • EVENTS
    • iGEM
      • News
      • Team
    • PHOTOS
    • VIDEO
    • WIKI
  • BLOG
  • COMMUNITY
    • FACEBOOK
    • INSTAGRAM
    • TWITTER
  • HOME
  • NEWS
  • EXPLORE
    • CAREER
      • Companies
      • Jobs
        • Lecturer
        • PhD Studentship
        • Postdoc
        • Research Assistant
    • EVENTS
    • iGEM
      • News
      • Team
    • PHOTOS
    • VIDEO
    • WIKI
  • BLOG
  • COMMUNITY
    • FACEBOOK
    • INSTAGRAM
    • TWITTER
No Result
View All Result
Bioengineer.org
No Result
View All Result
Home NEWS Science News Science

Genetesis CardioFlux™ platform receives FDA 510(k) clearance

Bioengineer by Bioengineer
March 22, 2019
in Science
Reading Time: 3 mins read
0
IMAGE
Share on FacebookShare on TwitterShare on LinkedinShare on RedditShare on Telegram

Next-generation magnetocardiography and cloud computing enable rapid, noninvasive cardiac imaging in the emergency department

IMAGE

Credit: Genetesis

(Mason, OH March 22, 2019 8 am) Genetesis, a medical technology company focused on using biomagnetic imaging to enable rapid, noninvasive and accurate chest pain triage, has received FDA 510(k) clearance for its cardiac imaging platform. The platform pairs the CardioFlux™ Magnetocardiograph with the integrated Faraday Analytical Cloud™ (FAC).

“This milestone provides emergency room physicians and cardiologists with access to new technology tomeasure and visualize the magnetic fields produced by the heart’s natural electrical activity,” said Peeyush Shrivastava, Genetesis Co-Founder and CEO.

CardioFlux™ technology enables simple, rapid, non-invasive cardiac imaging. CardioFlux represents a next-gen evolution of magnetocardiography (MCG); its use of optically pumped magnetometers (OPM) eliminates the need for liquid helium cooling, previously an obstacle to widescale commercial adoption of MCG. CardioFlux data is sent securely to the Faraday Analytical Cloud, from which physicians can review the functional imaging data, access a comprehensive set of web services, and hospitals can leverage an integrated billing service.

An investigational study using a prototype CardioFlux device was completed at Ascension St. John Hospital’s Emergency Department Observation Unit and presented by Margarita Pena, M.D., FACEP Medical Director, Clinical Decision Unit as a plenary session of the American College Emergency Physicians (ACEP) 2018 Scientific Assembly. “Throughout the study it became evident that there is great potential for magnetocardiography and CardioFlux to positively impact the clinical workflow of patients presenting to the ED with chest pain or anginal equivalents, which represent nearly 10 million emergency room visits a year.”

“Building on the initial investigational study at Ascension St. John Hospital, we see the value in magnetocardiography (MCG) along with the 20 years of clinical investigation on the use of MCG and the diagnosis of myocardial ischemia and coronary artery disease. Ascension St. John is now collaborating with several sites to launch the largest multi-center study using MCG, to date,” said Edouard Daher, M.D., FACC, Director, Cardiac Catheterization Labortaory at Ascension St. John Hospital.

Partho Sengupta, M.D., FACC, Chief, Division of Cardiology and Director, Cardiovascular Imaging, West Virginia University Heart and Vascular Institute, JW Ruby Memorial Hospital, said, “At WVU we see the potential impact of the use of magnetocardiography and CardioFlux and are in the process of implementing the CardioFlux system to conduct a study on the broader applicability to cardiovascular and coronary artery disease.”

“These are major steps forward by the team at Genetesis. Achieving these clinical and commercial milestones enables delivery of an end-to-end medical device and cloud computing platform focused on improving patient care and reducing costs.” said John Rice, Ph.D. Chairman of the Board of Directors at Genetesis, and Director of Life Sciences, CincyTech.

###

About Genetesis: Genetesis is a medical technology company based in Mason, Ohio creating and developing integrated biomagnetic imaging solutions to improve patients’ health, outcomes, and quality of life. For more information please visit us at http://www.genetesis.com.

Contacts:

Genetesis

Rick Karr, 614.368.9944

Vice President, Commercialization [email protected]

CincyTech

Peg Rusconi, 617-910-6217 Director of Communications [email protected]

Genetesis, CardioFlux and Faraday Analytical Cloud are pending trademarks of Genetesis, Inc.

Media Contact
Rick Karr
[email protected]

Original Source

https://www.businesswire.com/news/home/20190322005185/en/Genetesis-CardioFlux™-Platform-Receives-FDA-510-Clearance

Tags: Biomedical/Environmental/Chemical EngineeringCardiologyClinical TrialsCritical Care/Emergency MedicineHealth CareHealth Care Systems/ServicesMedicine/Health
Share12Tweet8Share2ShareShareShare2

Related Posts

Five or more hours of smartphone usage per day may increase obesity

July 25, 2019
IMAGE

NASA’s terra satellite finds tropical storm 07W’s strength on the side

July 25, 2019

NASA finds one burst of energy in weakening Depression Dalila

July 25, 2019

Researcher’s innovative flood mapping helps water and emergency management officials

July 25, 2019
Please login to join discussion

POPULAR NEWS

  • New Study Reveals the Science Behind Exercise and Weight Loss

    New Study Reveals the Science Behind Exercise and Weight Loss

    93 shares
    Share 37 Tweet 23
  • New Study Indicates Children’s Risk of Long COVID Could Double Following a Second Infection – The Lancet Infectious Diseases

    89 shares
    Share 36 Tweet 22
  • Physicists Develop Visible Time Crystal for the First Time

    75 shares
    Share 30 Tweet 19
  • New Insights Suggest ALS May Be an Autoimmune Disease

    67 shares
    Share 27 Tweet 17

About

We bring you the latest biotechnology news from best research centers and universities around the world. Check our website.

Follow us

Recent News

Self-Efficacy Modulates Nurses’ Response to Abusive Supervision

SNARE Neofunctionalization Driven by Vacuole Retrieval

Atractylodes lancea: Restoring Cardio-Renal Function in Rats

Subscribe to Blog via Email

Success! An email was just sent to confirm your subscription. Please find the email now and click 'Confirm' to start subscribing.

Join 62 other subscribers
  • Contact Us

Bioengineer.org © Copyright 2023 All Rights Reserved.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In
No Result
View All Result
  • Homepages
    • Home Page 1
    • Home Page 2
  • News
  • National
  • Business
  • Health
  • Lifestyle
  • Science

Bioengineer.org © Copyright 2023 All Rights Reserved.