Industry News

• In The News
  08.09.11

  PET with rubidium-82 predicts cardiac events

  Canadian researchers have found that PET scans with the radiopharmaceutical rubidium-82 can predict major adverse cardiac events independent of other parameters, according to a study published online August 9 in the Journal of the American College of Cardiology.

• In The News
  08.08.11

  Institute Of Medicine Clarifies It Is Not Seeking Tougher Bar For Class II Devices

  A week after issuing a scathing assessment of FDA’s 510(k) pre-market clearance program, the Institute of Medicine clarified that it is not recommending a tougher pre-market bar for all class II devices.

• In The News
  08.04.11

  Minn. pols defend FDA’s 510(k) process

  Both Minnesota’s senators and one congressman defended the Food and Drug Administration’s 510(k) clearance process from the Institute of Medicine’s calls to scrap it, with one senator slamming the IOM’s recommendations as “very harmful.”

• In The News
  08.03.11

  Studies show PET’s potential to differentiate dementia types

  PET has the potential to differentiate between types of dementia and to identify pharmaceuticals to slow the progress of the disease, according to two studies published in the August issue of the Journal of Nuclear Medicine.

• In The News
  08.02.11

  IOM: FDA Should Abandon 510(k) But Agency, Industry Disagree

  Other stakeholders agreed. “The IOM has offered the wrong approach,” MITA Executive Director David Fisher said. “Manufacturers have been working with the FDA and the broader imaging community to identify and implement targeted and effective improvements to the 510(k) review process,” the medical imaging group exec said.

• In The News
  07.29.11

  IOM urges FDA to scrap 510(k) device-clearance process

  The FDA, as well as the Advanced Medical Technology Association, which represents device makers, and the Medical Imaging and Technology Alliance said in separate statements that they do not support the IOM’s recommendation to scrap the 510(k) process.

• In The News
  07.28.11

  510(k) reform: FDA’s medical device unit review due out Friday

  The Institute of Medicine will release the highly anticipated results of its year-long investigation into the FDA’s medical device review process at the end of this week.

• In The News
  07.27.11

  FDA Announces Change to Medical Device Review Process

  The Food and Drug Administration released a draft guidance Tuesday that explains what types of changes to a previously approved device would require the manufacturer to submit a new request for approval.

• In The News
  07.26.11

  fMRI helps show physiologic differences in autistic children

  By combining functional MRI (fMRI) and passive speech stimulation, researchers at Columbia University Medical Center in New York have discovered physiologic differences between autistic and healthy children, according to a study in the August issue of Radiology.

• In The News
  07.25.11

  Industry Applauds FDA Draft Guidance On Mobile Medical Apps

  The medical device and software industries voiced support last week for a July 19 FDA draft guidance that helps clarify the types of mobile software applications that would face FDA regulation.