News & Updates

Check here regularly for news about medical imaging and updates from MITA.

• Industry 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.

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  The Food and Drug Administration released a draft guidance Tuesday that explains what types of changes to a previously approved device would require the manufacturer to submit a new request for approval.

• Industry 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.

• Industry 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  Industry Applauds FDA Draft Guidance On Mobile Medical Apps

  The medical device and software industries voiced support last week for a July 19 FDA draft guidance that helps clarify the types of mobile software applications that would face FDA regulation.

• Industry News
  07.22.11

  Lawmakers Advise Obama Against Cuts In Reimbursements for Medical Imaging

  A group of seven U.S. senators has urged President Barack Obama to reject calls for deeper Medicare cuts for medical imaging services.

• Industry News
  07.21.11

  Offer women mammograms from age 40: doctor’s group

  Doctors should offer all women in their 40s the chance to get annual screenings for breast cancer, according to new guidelines from an organization of women’s health professionals.

• Industry News
  07.20.11

  FDA proposes mobile medical apps guidance

  The U.S. Food and Drug Administration (FDA) has included medical imaging apps in a new draft guidance document for its regulation of mobile medical applications used on smartphones and other mobile computing devices.

• Industry News
  07.19.11

  Pediatric CT techniques scan hearts in a fraction of the dose

  New techniques for coronary CT angiography (CTA) — particularly high-pitch scanning — are slashing radiation dose levels to provide safer scans for children without the need for sedation, according to a study presented at last week’s Society of Cardiovascular Computed Tomography (SCCT) meeting in Denver.

• Industry News
  07.18.11

  Massachusetts Device Makers Urge FDA To Abandon Controversial 510(k) Reform Proposals

  Massachusetts device makers are pressing FDA to abandon the controversial 510(k) reform recommendations currently awaiting input from the Institute of Medicine.

• Industry News
  07.15.11

  ACR: Breast screening should begin at 40

  If women follow the breast cancer screening guidelines suggested in a study published in the July 5, 2011, issue of Annals of Internal Medicine, it could negate the benefits of mammography in women ages 40 and older and result in thousands of unnecessary breast cancer deaths each year…