• Popular
    • Medicine
    • Radiology
    • Cardiology
    • Surgery
    • Nanomedicine
    • Military Medicine
    • Rehab
  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS
  • Submit PR
  • Log in
Medgadget
Medgadget
  • Popular
    • Medicine
      Flexible Sensors Detect Heavy Metals in Sweat

      Flexible Sensors Detect Heavy Metals in Sweat

      Nanopore Sensor to Study Protein Aggregation in Neurodegeneration

      Nanopore Sensor to Study Protein Aggregation in Neurodegeneration

      Biobots Use Optogenetic Muscle Actuators for Movement

      Biobots Use Optogenetic Muscle Actuators for Movement

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

    • Radiology
      Ultrasound Tornado Rapidly Disrupts Blood Clots

      Ultrasound Tornado Rapidly Disrupts Blood Clots

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Fluorescence Imaging System Illuminates Tumor Depth

      Fluorescence Imaging System Illuminates Tumor Depth

      Soft Robot Grows Like a Plant to Travel Through Tight Spaces

      Soft Robot Grows Like a Plant to Travel Through Tight Spaces

    • Cardiology
      Belt Monitors Heart Failure Patients

      Belt Monitors Heart Failure Patients

      Camera Measures Blood Pressure with Quick Look

      Camera Measures Blood Pressure with Quick Look

      Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

      Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

    • Surgery
      Microneedle Bandage for Hemostatic Control

      Microneedle Bandage for Hemostatic Control

      Biobots Use Optogenetic Muscle Actuators for Movement

      Biobots Use Optogenetic Muscle Actuators for Movement

      Implantable Device Adheres to Muscle, Treats Atrophy

      Implantable Device Adheres to Muscle, Treats Atrophy

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

    • Nanomedicine
      Extra Hot Nanoparticles for Cancer Therapy

      Extra Hot Nanoparticles for Cancer Therapy

      Making Tumors Tastier for the Immune System

      Making Tumors Tastier for the Immune System

      Improved Membrane Coating for Anti-Cancer Nanoparticles

      Improved Membrane Coating for Anti-Cancer Nanoparticles

      Magnetic Bacteria Target Tumors

      Magnetic Bacteria Target Tumors

    • Military Medicine
      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fabric Makes Electricity from Movement to Power Wearables

      Fabric Makes Electricity from Movement to Power Wearables

      Wearable Uses Microneedles to Track Metabolism

      Wearable Uses Microneedles to Track Metabolism

    • Rehab
      Smart Walking Stick for Visually Impaired People

      Smart Walking Stick for Visually Impaired People

      Implantable Device Adheres to Muscle, Treats Atrophy

      Implantable Device Adheres to Muscle, Treats Atrophy

      Non-Invasive Spinal Modulation for Cerebral Palsy

      Non-Invasive Spinal Modulation for Cerebral Palsy

      Implanted Magnets for Prosthetic Control

      Implanted Magnets for Prosthetic Control

  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Log in
  • Submit PR
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS

FDA to Improve Post-Approval Device Monitoring

January 24th, 2006 Tim Odell Medicine


The FDA’s Center for Devices and Radiological Health is working to improve its monitoring of devices already in the field. According to Medical News Today:

Under the “Postmarket Transformation Initiative” the agency said it will develop an electronic reporting system for adverse reactions, standardize the identification process, obtain medical records of patients who use the devices, and increase communication with professional organizations and the medical device industry (CQ HealthBeat, 1/20). According to the Wall Street Journal, the program was addressed in an FDA report prepared internally that critiqued the agency’s handling and safety practices of medical devices such as defibrillators and pacemakers.
The report concluded that the current monitoring system at FDA’s Center for Devices and Radiological Health lacks “quality information” on approved devices, while at the same time the volume of information received “exceeds the center’s ability to consistently enter or review the data in a routine matter.”

It seems like the problem is this: in order to actively monitor the multitude of postmarket medical devices, the FDA needs to collect and process way more information than it can handle. They either need an army of data-crunchers or some really good database software.
Any IT entrepreneurs reading?
More from Medical News Today
Link to the FDA CDRH page outlining the details of their study and plans for action.

Tim Odell

Tim Odell started with Medgadget in 2005 while in graduate school at the University of Southern California. He prided himself on his irreverent tone and Pseudoscience Fridays series. After graduating in 2007, he began his career as a biomedical engineer with a Bioness, a neurorehabilitation start up, then moved on to Stryker in 2011.

Sponsored
C-mo Medical Solutions extends seed investment round to €4.8 million to transform cough monitoring

C-mo Medical Solutions extends seed investment round to €4.8 million to transform cough monitoring

New Clarius Power Fan HD3 Delivers a First for Handheld Ultrasound: Continuous Scanning

New Clarius Power Fan HD3 Delivers a First for Handheld Ultrasound: Continuous Scanning

Fluidx Unveils New Embolic for Neurovascular Use

Fluidx Unveils New Embolic for Neurovascular Use

Annalise.ai and Nuance Communications (a Microsoft Company) Announce Key Partnership to Improve Patient Outcomes with Workflow-Integrated AI

Annalise.ai and Nuance Communications (a Microsoft Company) Announce Key Partnership to Improve Patient Outcomes with Workflow-Integrated AI

PT Genie Unveils New Brand Identity Reflecting Company’s Transformation and Focus on the Global Future of AI and Machine Learning in Digital Healthcare

interviews & reviews
Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

Exciting Medtech at the Healthcareᐩ Expo Taiwan

Exciting Medtech at the Healthcareᐩ Expo Taiwan

Medgadget Visits Healthcareᐩ Expo Taiwan

Medgadget Visits Healthcareᐩ Expo Taiwan

Diabetes Management Tech for Type II patients: Interview with Jeffrey Brewer, CEO of Bigfoot Biomedical

Diabetes Management Tech for Type II patients: Interview with Jeffrey Brewer, CEO of Bigfoot Biomedical

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical's Greg Mielke

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical's Greg Mielke

Symani Microsurgical Robotic System: Interview with Mark Toland, CEO of Medical Microinstruments

Symani Microsurgical Robotic System: Interview with Mark Toland, CEO of Medical Microinstruments

  • Subscribe
  • Contact us
  • Submit
  • About
  • Back to top
Medgadget

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

  • About
  • Editorial policies
  • Contact
  • Terms of Service
  • Privacy
  • Submit press release
  • Advertise
© Medgadget, Inc. All rights reserved. | The Medical Revolution Will Be Blogged.
Please support this website by adding us to your whitelist in your ad blocker. Ads are what helps us bring you premium content! Thank you!
Posting....
  • Facebook
  • Twitter
  • LinkedIn
  • Reddit
  • Email