Navigation Links
FDA Approves Mechanical Cardiac Assist Device for Children With Heart Failure
Date:12/16/2011

d of care, although not FDA approved. Stroke, which can cause serious brain deficits, is a risk of the EXCOR Pediatric System.  

The EXCOR was designated as a Humanitarian Use Device (HUD) by the Office of Orphan Products Development at the FDA. This designation is for medical devices intended to benefit patients in the treatment or diagnosis of a disease or condition that affects fewer than 4,000 individuals in the United States annually. The device was approved under a Humanitarian Device Exemption (HDE), a type of marketing application that is similar to a premarket approval application in that the level of safety required for approval is the same. Rather than having to show a reasonable assurance of effectiveness, devices submitted under the HDE marketing route need to prove that the probable benefit from use of the device outweighs the probable risk of illness or injury from its use to obtain the FDA's approval.

The FDA approval of an HDE authorizes an applicant to market the device subject to certain use restrictions. After the passing of the Pediatric Medical Device Safety and Improvement Act of 2007, HUDs intended and labeled for use in a pediatric population are permitted to be marketed for profit.  

The FDA's Orphan Products Grant Program supported the U.S. clinical trials for the EXCOR Pediatric System with grants of $400,000 per year for three years.

For more information:

Designating Humanitarian Use Devices
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/DesignatingHumanitarianUseDevicesHUDS/default.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human u
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... 2014 /PRNewswire-iReach/ -- Transluminal Technologies LLC, a ... has announced today that they have received CE ... Device. Velox CD™ provides a safe and predictable ... procedures. The single size velox CD™ is indicated ... 5F to 8F.  Velox CD™ utilizes ...
(Date:7/30/2014)... 2014  InnoPharma, Inc. today announced the first generic ... of Zyprexa® injection), in Canada.  Olanzapine is indicated for ... patients with schizophrenia or bipolar I mania. ... has entered into an agreement with Sandoz Canada Inc., ... use, sell, market and distribute Olanzapine Injection in ...
(Date:7/30/2014)... TARRYTOWN, N.Y. and PARIS ... REGN ) and Sanofi (EURONEXT: SAN and ... new Phase 3 ODYSSEY trials of alirocumab in people ... greater percent reduction from baseline in low-density lipoprotein cholesterol ... comparator.  Alirocumab is an investigational monoclonal antibody targeting PCSK9 ...
Breaking Medicine Technology:Transluminal Technologies receives CE Mark approval for velox CD(TM) vascular closure device 2InnoPharma Announces Launch of Olanzapine for Injection, 10mg/vial in Canada 2Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 2Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 3Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 4Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 5Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 6Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 7Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 8
... WIXOM, Mich., Sept. 19 Rockwell Medical,Technologies, ... innovative manufacturer and,developer of concentrates and specialty ... announced today that it has commenced,enrollment in ... Ferric,Pyrophosphate (SFP), a physiological iron-maintenance therapy drug. ...
... ALEXANDRIA, La., Sept. 18 Life Recovery ... an emerging provider of,groundbreaking medical devices for the ... System has been granted European CE,Mark (Conformite Europeene) ... e.g., to induce hypothermia in patients to,preserve cardiac ...
Cached Medicine Technology:Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study 2Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study 3Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study 4Life Recovery Systems Receives European CE Mark Approval for Its ThermoSuit(R) System 2
(Date:7/30/2014)... Dennis Thompson HealthDay Reporter ... people with depression are more likely to develop dementia, but ... the relationship between the two. Specifically, they haven,t been ... works -- does depression help bring on dementia, or does ... published online July 30 in the journal Neurology ...
(Date:7/30/2014)... drug to treat malaria, is now widespread throughout ... ( P. falciparum ) parasites that cause the ... mutation in the parasites. However, a six-day course ... three-day coursehas proved highly effective in treating drug-resistant ... the New England Journal of Medicine . ...
(Date:7/30/2014)... Mozes HealthDay Reporter WEDNESDAY, ... help their preschooler shed excess pounds may want to team ... parents joined them in a supervised behavioral modification program gained ... traditional child-only program (an average difference of about four pounds ... 15 pounds over two years, according to the study. ...
(Date:7/30/2014)... (PRWEB) July 30, 2014 SF Cable, ... at the lowest prices on the internet with guaranteed ... in two lengths and two colors. These lightning cords ... , The high quality SF Cable Lightning ... with digital signal delivering faster charging and syncing. Compatible ...
(Date:7/30/2014)... Lexington, MA (PRWEB) July 30, 2014 ... provider of authentication, access management and secure communications ... Imprivata OneSign ® is the most widely ... using McKesson Paragon or Horizon electronic medical records ... (an increase of about 11 percent in the ...
Breaking Medicine News(10 mins):Health News:Scientists Shed Light on Link Between Depression, Dementia 2Health News:Scientists Shed Light on Link Between Depression, Dementia 3Health News:Resistance to key malaria drug spreading at alarming rate in Southeast Asia 2Health News:Make Kids' Weight Loss a Family Affair, Study Suggests 2Health News:Make Kids' Weight Loss a Family Affair, Study Suggests 3Health News:Make Kids' Weight Loss a Family Affair, Study Suggests 4Health News:SF Cable Delivers Certified Lightning Cable in Multiple Sizes and Colors 2Health News:Imprivata Achieves 51 Percent Single Sign-on Market Share Amongst U.S. Hospitals Using McKesson Paragon or Horizon EMR Systems, According to HIMSS Analytics 2
... Toronto Stock Exchange Symbol: CYT, MONTREAL, May ... cryotherapy products to treat cardiac,arrhythmias, today announced financial results ... Selected Second Quarter Financial and Operational Highlights:, - ... $10.2 million or a 37.6% ...
... N.Y., May 12 Gentiva Health,Services, Inc. (Nasdaq: ... services, announced today that it is scheduled to,present from ... 2008 at the 2008,Citi Investment Research Global Health Care ... available to the public via a live audio web,cast, ...
... IQ more likely the younger a child is at diagnosis, study ... 5 percent of people with multiple sclerosis are diagnosed when they,re ... function, causing memory and attention problems, and possibly low IQ scores. ... of diagnosis, the more likely he or she is to have ...
... even harm cognitive function , , MONDAY, May 12 (HealthDay News) ... daily use of two popular pain-relieving drugs, Celebrex and naproxen, ... history of Alzheimer,s disease. , In fact, naproxen, which goes ... a deleterious effect on cognitive function, the study found. ...
... than 2,000,hospital employees, patients and others concerned about the ... State House today in the "Care,Today, Gone Tomorrow" rally ... Toting signs that read "Some Cuts Never Heal" ... and state lawmakers to restore,the $143 million in charity ...
... Damir Matic, a scientist with Lawson Health Research Institute in ... performed throughout North America and around the world. Matic ... close the gum tissue of cleft palate patients. His research ... is older. , Matic is a craniofacial/plastic surgeon at London ...
Cached Medicine News:Health News:CryoCath Announces Fiscal 2008 Second Quarter Results 2Health News:CryoCath Announces Fiscal 2008 Second Quarter Results 3Health News:CryoCath Announces Fiscal 2008 Second Quarter Results 4Health News:CryoCath Announces Fiscal 2008 Second Quarter Results 5Health News:CryoCath Announces Fiscal 2008 Second Quarter Results 6Health News:CryoCath Announces Fiscal 2008 Second Quarter Results 7Health News:CryoCath Announces Fiscal 2008 Second Quarter Results 8Health News:CryoCath Announces Fiscal 2008 Second Quarter Results 9Health News:CryoCath Announces Fiscal 2008 Second Quarter Results 10Health News:CryoCath Announces Fiscal 2008 Second Quarter Results 11Health News:CryoCath Announces Fiscal 2008 Second Quarter Results 12Health News:Gentiva(R) Health Services to Present May 21 at 2008 Citi Investment Research Global Health Care Conference in New York 2Health News:Gentiva(R) Health Services to Present May 21 at 2008 Citi Investment Research Global Health Care Conference in New York 3Health News:Multiple Sclerosis Affects Children's Cognitive Skills 2Health News:Multiple Sclerosis Affects Children's Cognitive Skills 3Health News:Celebrex, Naproxen Won't Prevent Mental Decline 2Health News:Celebrex, Naproxen Won't Prevent Mental Decline 3Health News:Crowd Rallies to Protest Hospital Cuts 2Health News:Crowd Rallies to Protest Hospital Cuts 3Health News:Crowd Rallies to Protest Hospital Cuts 4Health News:Research shows timing improves cleft palate surgery 2
... F340 is a basic laboratory system for ... results can be obtained when used with ... electrode. • Fast and easy one and ... for five buffers (pH 1.68, 4.00, 7.00, ...
... the multifunctional high-end microplate reader with outstanding ... modes., Fluorescence Intensity - FRET , ... HTRF, AlphaScreen , Luminescence , ... emission microplate reader with fastest read times. ...
... microplate reader combines improved flexibility ... with a wide range of ... the flexibility, sensitivity and high ... is the ideal detection solution ...
... for Ultra High Throughput Screening (UHTS), ... detection performance. Allows for smooth transfer ... development by sharing all the detection ... fluorescence intensity, fluorescence polarization, time-resolved fluorescence, ...
Medicine Products: