Medical Breakthroughs Reported by Click here to go to the homepage.
Be the First to Know. Click here to subscribe FREE!
Search Reports: Use quotation marks around your multi-word search terms in the box below to perform search of
Advances in health and medicine.Use " marks around search terms
What's New
News Flash
  Alternative Health
Asthma & Allergies
Breast Cancer
Cardiovascular Health
Children's Health
Dental Health
Fertility & Pregnancy
Men's Health
Mental Health
Multiple Sclerosis
Neurological Disorders
Nutrition & Wellness
Pet Health
Seniors' Health
Sports Medicine
Women's Health
Advances in health and medicine.
Click here to sign up for Medical Alerts!
Click below to access other news from Ivanhoe Broadcast News.
  Click here to get Ivanhoe's Medical Headline RSS feed Click here to listen to Ivanhoe's Medical Podcasts
Useful Links
Play It Again, Please
E-Mail a Friend
Order Books Online
Inside Science
Smart Woman
Advances in health and medicine.
Smart Woman Home
Click here to read the story
Click here to read the story
Click here to read the story
Smart Woman Home
Advances in health and medicine.
Click below to learn about Ivanhoe.
About Us
Contact Us
Ivanhoe FAQ
Our TV Partners
Travel Calendar
Advances in health and medicine.
Ivanhoe celebrates 20 years of medical news reporting reaching nearly 80 million TV households each week. Click here to learn more...
Advances in health and medicine.
Marjorie Bekaert Thomas
Advances in health and medicine.
General Health Channel
Reported January 20, 2014

Fast Track for Fast FDA Approval

ORLANDO, Fla. (Ivanhoe Newswire) – In 1996, the FDA established the humanitarian device exemption, or HDE, for medical devices.  Companies could gain FDA approval through the exemption by simply showing their product provided a benefit to patients. The FDA only grants these exemptions to devices that treat conditions affecting less than 4 thousand people a year.

It’s fast and it’s saving lives! In the past 15 years, 50 medical devices have been sold and used under the HDE provision.

One of the most recent is a device called the BSD-2000. It was approved for women with cervical cancer who are too sick for chemo.

The device uses microwaves to heat the body up to 104 degrees to kill cancer cells. Despite its development in the 1980’s, the device has yet to gain medical acceptance or full FDA approval.

The most recent approval is for the Liposorber LA-15 system.

The device treats children with primary focal segmental glomerulosclerosis, called FSGS, a chronic condition where scar tissue blocks filters in the kidneys and can cause blood to lose protein. FSGS is the second leading cause of kidney failure in children. 

The system removes blood, separates the plasma, and then absorbs lipoproteins, which can worsen the disease. The treated plasma and blood are then returned to the body.

The FDA allows companies to sell these exempt devices for profit. Critics of the process say it puts untested devices into the medical community and companies can use it as a loophole to get their product to market faster.  MORE.

More Information

Click here for additional research on Fast Track for Fast FDA Approval

If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas,



Related Articles in Latest Medical News:

 Doctor Contact
Medical Alerts!

[ Back to General Health Channel Home ]

Most Recent Videos
Your Baby DVD
What Every Pregnant Woman Should Know

Happier Woman DVD
25 ways to reduce stress

Forever Young DVD
25 ways to lose 10 years

Feel Good Again DVD
25 ways to STOP THE PAIN

If a treatment you read about here helps you, let us know...Click here!!

Follow Us On:

Click here to go to Ivanhoe's Twitter page Click here to go to Ivanhoe's Facebook page Click here to go to Ivanhoe's YouTube page

Do you know if you are height-weight proportional?

Find out your Body Mass Index (BMI).

Click Here


How safe are your dietary supplements?

Click here to find out with the FDA's list of supplements and drug interactions.

Home | What's New | News Flash | Search/Latest Medical News | E-Mail Medical Alerts!
Ivanhoe FAQ | Privacy Policy | Our TV Partners | Awards | Useful Links | Play It Again, Please
RSS Feeds | Advertising/Sponsorships | Content Syndication | Reprints

Advances in health and medicine.
Copyright © 2016 Ivanhoe Broadcast News, Inc.
2745 West Fairbanks Avenue
Winter Park, Florida 32789
(407) 740-0789

P.O. Box 865
Orlando, Florida 32802

Premium Content in Latest Medical News Denotes Premium Content in Latest Medical News