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.
Can AI Predict Future Lung Cancer Risk from a Single CT Scan?
May 19th 2025In never-smokers, deep learning assessment of single baseline low-dose computed tomography (CT) scans demonstrated a 79 percent AUC for predicting lung cancer up to six years later, according to new research presented today at the American Thoracic Society (ATS) 2025 International Conference.
What if Radiology Turns Out Exactly the Way We Predict it Will?
May 19th 2025Whether it is reimbursement cuts or continued attempts to push non-radiologist image interpretation, where do we draw the line between inspired protest and misspent energy criticizing things that are doomed to fail or things we have no control over?
What a New PSMA PET/CT Study Reveals About Local PCa Treatment and High-Risk Recurrence
May 16th 2025For patients at high-risk for biochemical recurrence of prostate cancer, PSMA PET/CT findings revealed that 77 percent had one or more prostate lesions after undergoing local radiation therapy or radical prostatectomy, according to a recent study.