FDA accepts Imation’s reply to warning
Imation of Oakdale, MN, announced June 11 that the Food and Drug Administration has accepted its plan for dealing with concerns outlined in a warning letter it received from the FDA last month (SCAN 6/10/98). The letter was the result of a
Imation of Oakdale, MN, announced June 11 that the Food and Drug Administration has accepted its plan for dealing with concerns outlined in a warning letter it received from the FDA last month (SCAN 6/10/98). The letter was the result of a scheduled FDA visit in April to Imation's laser printer manufacturing facility, where the agency discovered inadequate links between Imation's documentation systems. In its reply, the company detailed a consistent documentation system that satisfies FDA requirements and clarified the connections between its existing documentation systems.
The Reading Room Podcast: Current Perspectives on the Updated Appropriate Use Criteria for Brain PET
March 18th 2025In a new podcast, Satoshi Minoshima, M.D., Ph.D., and James Williams, Ph.D., share their insights on the recently updated appropriate use criteria for amyloid PET and tau PET in patients with mild cognitive impairment.
Can Photon-Counting CT be an Alternative to MRI for Assessing Liver Fat Fraction?
March 21st 2025Photon-counting CT fat fraction evaluation offered a maximum sensitivity of 81 percent for detecting steatosis and had a 91 percent ICC agreement with MRI proton density fat fraction assessment, according to new prospective research.
