FDA To Review Safety Of Electroshock Devices

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FDA To Review Safety Of Electroshock Devices

medicalnewstoday.com

Despite ongoing controversy, there has never been a large-scale, prospective study of the cognitive effects of electroconvulsive therapy (ECT). Dr. Harold Sackeim, et al, 2007. T

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Most Recently Shared on January 26, 2011 at 2:36 am By:

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FDA To Review Safety Of Electroshock Devices: "Despite ongoing controversy, there has never been a large-scale, ... http://bit.ly/dKXylr

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FDA Working To Reduce 'Alarm Fatigue' Through Tougher Device Reviews - iHealthBeat

ihealthbeat.org — “FDA is taking steps to curb 'alarm fatigue' in hospitals by increasing its pre-market scrutiny of medical devices that issue potentially unnecessary alarms. For example, the agency is providing its reviewers with additional training on alarm standards and safety. Boston Globe.View full resource at ihealthbeat.org

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Most Recently Shared on March 26, 2012 at 6:44 pm By:

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FDA Working To Reduce 'Alarm Fatigue' Through Tougher Device Reviews - http://t.co/M8fjbpc5

2 months ago...

FDA working to trim hospital ‘alarm fatigue’ - Boston.com

bostonglobe.com — “The Food and Drug Administration is taking steps to reduce “alarm fatigue’’ in hospitals by intensifying its pre-market review of medical devices that sound alarms and could contribute to theView full resource at bostonglobe.com

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Most Recently Shared on March 26, 2012 at 5:15 pm By:

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FDA working to trim hospital ‘alarm fatigue’ - Health & wellness - The Boston Globe http://t.co/OyKko7Cn

2 months ago...

FDA working to trim hospital ‘alarm fatigue’ - Health & wellness - The Boston Globe

bostonglobe.com — “The US Food and Drug Administration is seeking to reduce “alarm fatigue’’ in hospitals by intensifying its pre-market review of medical devices that sound alarms and could contribute to the desensitization of nurses - a problem that the Globe reported last year was linked to hundreds of deaths. The agency is providing additional training on alarm standards and alarm safety to its reviewers, who are responsible for scrutinizing 4,000 applications a year from device manufacturers.View full resource at bostonglobe.com

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FDA working to trim hospital ‘alarm fatigue’ - Health & wellness - The Boston Globe

bostonglobe.com — “The US Food and Drug Administration is seeking to reduce “alarm fatigue’’ in hospitals by intensifying its pre-market review of medical devices that sound alarms and could contribute to the desensitization of nurses - a problem that the Globe reported last year was linked to hundreds of deaths. The agency is providing additional training on alarm standards and alarm safety to its reviewers, who are responsible for scrutinizing 4,000 applications a year from device manufacturers.View full resource at bostonglobe.com

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Most Recently Shared on March 26, 2012 at 12:02 pm By:

Clinica - US FDA guidance: continuing reviews by IRBs and information drug, device sponsors should submit

clinica.co.uk — “The US FDA has released a final a href=View full resource at clinica.co.uk

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Most Recently Shared on March 8, 2012 at 10:03 pm By:

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@US_FDA issues final guidelines on performing continuing reviews to ensure #safety of participants in #clinical #trials http://t.co/PeszE1wj

3 months ago...

FDA investigating illegal online sale of handheld dental X-ray units

fda.gov — “The U.S Food and Drug Administration is warning dental and veterinary professionals to not purchase or use certain potentially unsafe hand-held dental X-ray units. The FDA is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays. The units, sold online by manufacturers outside the United States and directly shipped to U.S. customers, have not been reviewed by the FDA and do not meet FDA radiation safety rView full resource at fda.gov

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Most Recently Shared on February 10, 2012 at 3:50 pm By:

eyeonfda eyeonfda Pharma and Health Lawyer

#FDA investigating illegal online sale of handheld dental X-ray units http://t.co/G3qy37Y7

4 months ago...

Senators propose relaxing FDA conflict rules | Reuters

reuters.com — “WASHINGTON (Reuters) - A bill that would loosen conflict of interest rules for advisers to the Food and Drug Administration has been proposed by three U.S. senators seeking to speed up review times forView full resource at reuters.com

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Most Recently Shared on October 14, 2011 at 4:54 pm By:

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Bill allowing drug company experts to sit on FDA panels will compromise drug and medical device safety http://t.co/cFOgrwq9 @AnnaHealth

7 months ago...

FDA, Medicare to review medical devices in tandem | Reuters

reuters.com — “(Reuters) - U.S. health officials are launching a trial of a program meant to speed up Medicare payment decisions for new medical devices.The Food and Drug Administration, which regulates the safety andView full resource at reuters.com

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Most Recently Shared on October 8, 2011 at 1:05 pm By:

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FDA, Medicare to review medical devices in tandem | Reuters http://t.co/Tr3RYouF via @reuters

8 months ago...

FDA, Medicare to review medical devices in tandem | Reuters

reuters.com — “(Reuters) - U.S. health officials are launching a trial of a program meant to speed up Medicare payment decisions for new medical devices.The Food and Drug Administration, which regulates the safety andView full resource at reuters.com

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Most Recently Shared on October 7, 2011 at 7:42 pm By:

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FDA, Medicare to review medical devices in tandem http://t.co/vWagYX03

8 months ago...

Medical News: FDA Reviewers Call for Harder Look at Transvaginal Mesh - in Washington-Watch, FDA General from MedPage Today

medpagetoday.com — “Transvaginal mesh devices should not be approved for surgical repair of pelvic organ prolapse through the less-rigorous 510(k) process because of safety concerns, according to FDA staff reviewers.View full resource at medpagetoday.com

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Most Recently Shared on September 15, 2011 at 10:40 pm By:

Medical News: FDA Reviewers Call for Harder Look at Transvaginal Mesh - in Washington-Watch, FDA General from MedPage Today

medpagetoday.com — “Transvaginal mesh devices should not be approved for surgical repair of pelvic organ prolapse through the less-rigorous 510(k) process because of safety concerns, according to FDA staff reviewers.View full resource at medpagetoday.com

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Most Recently Shared on September 7, 2011 at 11:13 pm By:

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FDA reviewers call for harder look at transvaginal mesh: http://t.co/soC4ZgR

9 months ago...

Public Health Effectiveness of the FDA 510(k) Clearance Process - Institute of Medicine

iom.edu — “An IOM committee is convening to review the 510(k) clearance process for medical devices that are “substantially equivalent” to currently marketed products and assess whether the process protects and promotes the public health.View full resource at iom.edu

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Most Recently Shared on August 1, 2011 at 3:03 pm By:

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IOM recommends a "reasonable assurance of safety and effectiveness" of medical devices http://t.co/uZJ0Naw

10 months ago...

FDA is urged to revamp its review process for medical devices - OrlandoSentinel.com

orlandosentinel.com — “The Food and Drug Administration should stop permitting thousands of medical devices to be marketed and used in patients without proof of safety or effectiveness, the National Academy of Sciences said Friday.View full resource at orlandosentinel.com

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Most Recently Shared on July 29, 2011 at 9:58 pm By:

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FDA is urged to revamp review process for medical devices: The National Academy of Sciences says in an FDA-c... http://thesent.nl/mXLz60

10 months ago...

FDA is urged to revamp its review process for medical devices - latimes.com

latimes.com — “The Food and Drug Administration should stop permitting thousands of medical devices to be marketed and used in patients without proof of safety or effectiveness, the National Academy of Sciences said Friday.View full resource at latimes.com

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Most Recently Shared on July 29, 2011 at 3:50 pm By:

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FDA is urged to revamp its review process for medical devices http://lat.ms/qjOvWs

10 months ago...

Sapien Heart Valve That Avoids Open Heart Surgery Impresses FDA Reviewers But Safety Concerns Remain

medicalnewstoday.com — “Edwards Lifesciences' new Sapien transcatheter heart valve, an experimental device designed to be inserted through an artery without the need for open heart surgery, appears to have impressed USView full resource at medicalnewstoday.com

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Most Recently Shared on July 20, 2011 at 8:06 am By:

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@medhealthnews Sapien Heart Valve That Avoids Open Heart Surgery Impresses FDA Reviewers But Saf... http://bit.ly/rdQ9s6 #heart #surgery

10 months ago...

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