The Food and Drug Administration'sCenter for Devices and Radiological Health will discuss the classificationof PACS devices at a hearing to be held Aug. 29. The hearing willbe conducted by the Medical Devices Advisory Committee's radiologicaldevices
The Food and Drug Administration'sCenter for Devices and Radiological Health will discuss the classificationof PACS devices at a hearing to be held Aug. 29. The hearing willbe conducted by the Medical Devices Advisory Committee's radiologicaldevices panel.
PACS devices do not have their own classification and insteadare categorized as radiology accessories for purposes of governmentregulation. The rapid growth of PACS suggests that the devicesbe given their own classification, according to Robert Phillipsof the CDRH.
The panel will also discuss minor changes to PACS regulation.For example, the FDA may ease off on requirements that storageand communication devices receive 510(k) clearance before theycan be marketed, Phillips said.
The FDA is seeking industry participation in the hearing, whichwill be held at 2:30 p.m. in Room G of the Parklawn building atthe FDA's headquarters at 5600 Fishers Lane in Rockville, MD.For more information call Phillips at 301/594-1212.
Where Things Stand with the Radiologist Shortage
June 18th 2025A new report conveys the cumulative impact of ongoing challenges with radiologist residency positions, reimbursement, post-COVID-19 attrition rates and the aging of the population upon the persistent shortage of radiologists in the United States.
Can Contrast-Enhanced Mammography be a Viable Screening Alternative to Breast MRI?
June 17th 2025While the addition of contrast-enhanced mammography (CEM) to digital breast tomosynthesis (DBT) led to over a 13 percent increase in false positive cases, researchers also noted over double the cancer yield per 1,000 women in comparison to DBT alone.