• Home
  • About
  • Contact
  • Privacy
  • DCMA
  • Terms
  • Sitemap
  • Submit
Friday, May 9, 2025
Chicago Digital Post
  • News
    • Politics
    • Sports
  • Business
    • Marketing
    • Crypto
    • Real Estate
  • Education
  • Technology
  • Health
    • Fitness
    • Food
    • Travel
  • Lifestyle
    • Relationship
    • Movies
    • Music
  • Vehicles
No Result
View All Result
Chicago Digital Post
  • News
    • Politics
    • Sports
  • Business
    • Marketing
    • Crypto
    • Real Estate
  • Education
  • Technology
  • Health
    • Fitness
    • Food
    • Travel
  • Lifestyle
    • Relationship
    • Movies
    • Music
  • Vehicles
Chicago Digital Post
No Result
View All Result
Home Health

FDA releases draft guidance for Breakthrough Devices Program aimed at health inequities

by Staff Writer
October 23, 2022
in Health
Reading Time: 2 mins read
0
FDA releases draft guidance for Breakthrough Devices Program aimed at health inequities
74
SHARES
1.2k
VIEWS
Share on FacebookShare on Twitter

Table of Contents

Toggle
  • You might also like
  • Medtech startup See-Mode gets Canada’s nod for AI breast, thyroid ultrasound analysis software
  • Answers to “Why Can’t I Sleep?” and Other Sleep Problems
  • Censorship Wasn’t Enough, They Want to Destroy Us

You might also like

Medtech startup See-Mode gets Canada’s nod for AI breast, thyroid ultrasound analysis software

Answers to “Why Can’t I Sleep?” and Other Sleep Problems

Censorship Wasn’t Enough, They Want to Destroy Us

The FDA on Thursday released draft guidance for its Breakthrough Devices Program aimed at reducing health disparities.

The draft proposes updates that would clarify how the program would apply to medical devices that could benefit groups affected by health inequities, including disparities based on race, sex, ethnicity and access to care. The agency will also assess if the developers have considered how pathology, response to treatment and clinical features can vary depending on these factors. 

Additionally, the draft notes people with rare diseases or disorders also face health disparities, as they may have fewer diagnostic or treatment options. It also includes a section that proposes non-addictive medical products that treat pain or substance use disorders may be eligible for the program.

Lastly, the draft adds a section to the designation review process noting the FDA will not disclose the existence of requests for Breakthrough Device Designation or its decision unless the device obtains marketing authorization or if the company publicly discloses the request for designation. 

“The FDA is committed to advancing the development of safe and effective technologies to meet the needs of all patients and consumers. This draft guidance, once finalized, can help FDA and our stakeholders leverage the interactive nature of the Breakthrough Devices Program to move us closer to achieving our new Strategic Priority to Advance Health Equity, where technologies, including digital health technologies, can help advance better health care, quality of life and wellness for all communities, and meet the needs of diverse populations,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. 

The Breakthrough Devices Program is not a marketing authorization but a program aiming to identify and provide patients and healthcare professionals with timely access to devices that can provide more effective treatment or diagnosis of irreversibly debilitating or life-threatening conditions. 

Interested parties can submit comments on the draft by Dec. 20. 

Source by www.mobihealthnews.com

Share30Tweet19

Recommended For You

Medtech startup See-Mode gets Canada’s nod for AI breast, thyroid ultrasound analysis software
Health

Medtech startup See-Mode gets Canada’s nod for AI breast, thyroid ultrasound analysis software

See-Mode Technologies, a medtech startup based in Melbourne, Australia and Singapore, has received the approval of Health Canada for its software product that supports breast and thyroid ultrasound...

by Staff Writer
November 17, 2022
Answers to “Why Can’t I Sleep?” and Other Sleep Problems
Health

Answers to “Why Can’t I Sleep?” and Other Sleep Problems

Reviewed by Jennifer Martin, PhD Google hears about everyone’s sleep problems, at all hours of the night. And chances are, if BILLIONS of people are wondering why they...

by Staff Writer
November 17, 2022
Censorship Wasn’t Enough, They Want to Destroy Us
Health

Censorship Wasn’t Enough, They Want to Destroy Us

Cyberwar is currently taking place on several levels. On the international level, China and Russia in particular have become known for their hacking skills. As reported by “Full...

by Staff Writer
November 16, 2022
Do You Really Want To Read What Your Doctor Writes About You?
Health

Do You Really Want To Read What Your Doctor Writes About You?

You may not be aware of this, but you can read everything that your doctor writes about you. Go to your patient portal online, click around until you...

by Staff Writer
November 16, 2022
How Bladder Cancer Differs in Women and Younger Adults
Health

How Bladder Cancer Differs in Women and Younger Adults

Bladder cancer is one of the most commonly diagnosed forms of cancer in the U.S. About 1 in 40 Americans born today will develop this cancer at some...

by Staff Writer
November 16, 2022
Cybersecurity threats are top of mind for healthcare CIOs and CISOs
Health

Cybersecurity threats are top of mind for healthcare CIOs and CISOs

The future of healthcare is being driven by innovation and digital transformation, with a heightened focus on open-standards interoperability and distributed ecosystems.    While the acceleration of digital technologies,...

by Staff Writer
November 15, 2022

Related News

How to Back Up Your Docker Volumes

How to Back Up Your Docker Volumes

October 22, 2022

Kuwait’s credit rating is cut amid concern over government finances

January 9, 2022
Manhattan College fires basketball coach Steve Masiello

Manhattan College fires basketball coach Steve Masiello

October 27, 2022

Browse by Category

  • Articles
  • Business
  • Crypto
  • Education
  • Fitness
  • Food
  • Health
  • Lifestyle
  • Movies
  • Music
  • Politics
  • Real Estate
  • Sports
  • Technology
  • Travel
  • Vehicles
Chicago Digital Post

Chicago Digital Post! is a Digital web magazine covering topics related to tech and the latest news about Chicago, Illinois, sports, movies, pop culture, fashion, beauty, fitness, and politics at your fingertips. Read More...

CATEGORIES

  • Articles
  • Business
  • Crypto
  • Education
  • Fitness
  • Food
  • Health
  • Lifestyle
  • Movies
  • Music
  • Politics
  • Real Estate
  • Sports
  • Technology
  • Travel
  • Vehicles

Submit A News | Write For Us

Feel free to contact us for submission queries. via contact form or email us at: [email protected]

© 2021 chicagodigitalpost.com

  • Home
  • About
  • Contact
  • Privacy
  • DCMA
  • Terms
  • Sitemap
  • Submit
No Result
View All Result
  • News
    • Politics
    • Sports
  • Business
    • Marketing
    • Crypto
    • Real Estate
  • Education
  • Technology
  • Health
    • Fitness
    • Food
    • Travel
  • Lifestyle
    • Relationship
    • Movies
    • Music
  • Vehicles