Navigation Links
Study Questions FDA Approvals of Cardiac Devices
Date:12/29/2009

Review suggests evaluations are not as stringent as with new medications

TUESDAY, Dec. 29 (HealthDay News) -- The U.S. Food and Drug Administration may not be as stringent in evaluating devices as it is in approving drugs.

According to a report in the Dec. 23/30 issue of the Journal of the American Medical Association, approval of cardiovascular devices often sails through based on studies that are not randomized or blinded, and sometimes even on the basis of one study alone.

"While we did not expect that all studies would be or should be randomized and blinded, we were surprised that the numbers of such studies were as low as they were and that there were many devices approved on the basis of a single study," said study senior author Dr. Rita Redberg, a professor of medicine at the University of California, San Francisco.

Redberg is also a member of the FDA Circulatory System Devices Panel, which advises the FDA on regulatory issues pertaining to these kinds of devices.

For its part, the FDA on Tuesday issued a statement in which it said the study presented an "inaccurate picture" of the clinical trials used in the agency's heart device review process, noting that devices and drugs are not the same thing and require different processes for approval.

One outside expert agreed that the researchers' conclusions were too harsh.

"I have been through the [device approval] process often enough with the FDA to know that these types of criticism don't reflect the typical standard of FDA behavior," said Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City.

The problem with this study, Garratt pointed out, may be that the authors tried to look at too many different types of devices, not all of which have the same impact on the patient and not all of which can be randomized or blinded.

Still, there might
'/>"/>

Copyright©2009 ScoutNews,LLC.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Penn study finds pro-death proteins required to regulate healthy immune function
2. New study shows promise in reducing surgical risks associated with surgical bleeding
3. Study, meta-analysis examine factors associated with death from heatstroke
4. Study suggests loss of 2 types of neurons -- not just 1 -- triggers Parkinsons symptoms
5. Study says COPD testing is not measuring up
6. Preclinical study suggests organ-transplant drug may aid in lupus fight
7. Ability to cope with stress can increase good cholesterol in older white men, study finds
8. High alcohol consumption increases stroke risk, Tulane study says
9. Mailman School of Public Health study examines link between racial discrimination and substance use
10. Pitt study finds inequality in tobacco advertising
11. Stanford study highlights cost-effective method of lowering heart disease risks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/25/2015)... York New York (PRWEB) April 25, 2015 ... that Dr. Jerry Blaivas has been chosen by the New ... for his contributions to medicine in the field of Urology. ... the best in his speciality, Genito-Urinary diseases. He was ... specifically in the field of urology. Not only did ...
(Date:4/25/2015)... (PRWEB) April 25, 2015 On Friday, ... of RFID Journal’s annual Best Implementation Award. This ... demonstrated the best use of RFID technology to improve ... is the company that best demonstrates how RFID is ... presented at RFID Journal Live! 2015 in San Diego, ...
(Date:4/24/2015)... 24, 2015 Bird B Gone, the leader ... now offers a complete line of bird control solutions to ... , New Flu Strains Threaten Pacific, Central and Mississippi Farms ... , a number of highly pathogenic avian flus in ... is often spread when wild birds enter poultry farms. The ...
(Date:4/24/2015)... (PRWEB) April 24, 2015 Multi Customer ... septic tank pumping ( http://www.zeitersseptics.com/multi-customer-discount.html ) of 1000-1500 gallons ... start the program. This does not include any Dig ... Save $25-$65 per person. If someone is part of ... two tanks totaling approximately 2500 gallons or more, the ...
(Date:4/24/2015)... 2015 Ryadon is a leading manufacturer ... capabilities and services to complement any custom hardware requirements ... Program will be offered on all heavy duty drawer ... Receive 10% discount - Order 20+: Receive 20% discount ... Slides Products, Furniture ,Drawer ...
Breaking Medicine News(10 mins):Health News:The 2015 Valentine Award Comes From The Heart and Goes To Famous New York Urologist 2Health News:The 2015 Valentine Award Comes From The Heart and Goes To Famous New York Urologist 3Health News:Seeonic’s Industry Leading Technology Powers Interstate Batteries to Winning Award 2Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 2Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 3Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 4Health News:Zeiter's Septics Inc. Offers Multi Customer Septic Tank Cleaning Program in Cook, Putnam & Will Counties in May 2015 2Health News:Zeiter's Septics Inc. Offers Multi Customer Septic Tank Cleaning Program in Cook, Putnam & Will Counties in May 2015 3Health News:Ryadon Inc. Offers Quantity Drawer Slide Discount Program Nationwide in May 2015 2Health News:Ryadon Inc. Offers Quantity Drawer Slide Discount Program Nationwide in May 2015 3
... N.Y., JAN. 5, 2009 Only 17 percent of ... are taking a multivitamin containing folic acid daily, according ... to focus on this population. , Folic acid ... of the brain and spine such as spina bifida ...
... Jan. 5 Only 17 percent of Spanish-speaking women ... a multivitamin containing folic acid daily, according to the ... on this population. Folic acid can prevent neural tube ... spine such as spina bifida and anencephaly, which are ...
... Volcano Corporation,(Nasdaq: VOLC ), a leader ... diagnosis and treatment of coronary and peripheral artery,disease, will ... to,discuss its acquisition of Axsun Technologies, Inc., that was ... The teleconference call and webcast will begin at 1 ...
... Conference on Cell Therapy for Cardiovascular Disease (IC3D) will ... organ injury. The session will include new data on ... cells for stroke patients, and treating Parkinson,s disease with ... include the first human data using special bone marrow ...
... Newswire Staff Volunteer Time As Part of ... Jan. 5 Ronald McDonald House of Cleveland ... non-profit organizations serving the Cleveland community, were the ... from PR Newswire,s Cleveland staff in 2008, PR ...
... OF THE AMERICAN SOCIETY OF PLASTIC SURGEONSARLINGTON HEIGHTS, Ill., ... the American Society of Plastic Surgeons:Can The US Really ... that while health care is one of the strongest ... sustainable reduction is US health care spending is not ...
Cached Medicine News:Health News:Folic acid survey of Spanish-speaking women finds most are missing benefits, March of Dimes says 2Health News:First Nationwide Folic Acid Survey of Spanish-Speaking Women Finds Most Are Missing Benefits, March of Dimes Says 2Health News:First Nationwide Folic Acid Survey of Spanish-Speaking Women Finds Most Are Missing Benefits, March of Dimes Says 3Health News:Reminder: Volcano Corporation Schedules Conference Call, Webcast to Discuss Axsun Transaction 2Health News:Conference on cell therapy includes new session on stem cells for non-cardiac organ injury 2Health News:PR Newswire Provides Grant to Ronald McDonald House and Habitat for Humanity in Cleveland 2Health News:PR Newswire Provides Grant to Ronald McDonald House and Habitat for Humanity in Cleveland 3Health News:PR Newswire Provides Grant to Ronald McDonald House and Habitat for Humanity in Cleveland 4Health News:PR Newswire Provides Grant to Ronald McDonald House and Habitat for Humanity in Cleveland 5Health News:Plastic and Reconstructive Surgery...In Brief 2Health News:Plastic and Reconstructive Surgery...In Brief 3
(Date:4/23/2015)... HILL, S.C. , April 23, 2015 ... on and strengthening our commitment to patient safety. ... in the fight against infectious disease. The ... Medical gas sensors are now mounted in ... reducing the need to open ceiling tiles potentially releasing ...
(Date:4/23/2015)... April 23, 2015 Nektar Therapeutics (Nasdaq: NKTR ... ended March 31, 2015 on Thursday, April 30, 2015, after ... president and chief executive officer, will host a conference call ... (ET)/2:00 p.m. Pacific Time (PT). The press ... can be accessed through a link that is posted on ...
(Date:4/23/2015)... 23, 2015  DanDrit Biotech A/S ("DanDrit Denmark"), ... , Inc. ("DanDrit"), (symbol : OTCQB:DDRT) a ... for the treatment of colorectal cancer, announced that ... signed a partnership agreement in Saudi ... advances DanDrit,s goal to deliver an innovative portfolio ...
Breaking Medicine Technology:BeaconMedaes launches new Zone Valve Box Assembly 2Nektar to Announce Financial Results for the First Quarter 2015 on Thursday, April 30, 2015, After Close of U.S.-Based Financial Markets 2DanDrit Biotech and Riyadh Pharma Sign Partnership Agreement 2
... 2011 Henry Schein, Inc. (NASDAQ: ... services to office-based practitioners, announced today that Ferdinand ... the CL King 9th Annual Best Ideas Conference 2011. The ... New York City. Henry Schein,s presentation is ...
... VILLAGE, Nev., Sept. 13, 2011 PDL BioPharma, Inc. (PDL) ... McLaughlin, the company,s president and chief executive officer, will present ... ) UBS Global Life Sciences Conference ... The JMP Securities Healthcare Conference Tuesday, ...
Cached Medicine Technology:Henry Schein to Present at the CL King 9th Annual Best Ideas Conference 2011 2
HME w/CO2 Sampling Port 22mm od/15mm od...
... T helps provide protection to the exposed airway ... extremely lightweight making it ideal for active young ... rate of heat and moisture recovery, it ensures ... HMEs and filters have ISO standard tapered ends ...
... provide protection to the exposed airway of the ... making it ideal for active young children as ... heat and moisture recovery, it ensures patient comfort ... filters have ISO standard tapered ends to assure ...
The Secretion Solution., ,Available Configurations: , Straight Flex Tube, Poppel Flex Tube, MDI Adaptor ...
Medicine Products: