- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
FDA to hold PACS classification hearing
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.
European Society of Breast Imaging Issues Updated Breast Cancer Screening Recommendations
April 24th 2024One of the recommendations from the European Society of Breast Imaging (EUSOBI) is annual breast MRI exams starting at 25 years of age for women deemed to be at high risk for breast cancer.
Study Reveals Benefits of Photon-Counting CT for Assessing Acute Pulmonary Embolism
April 23rd 2024In comparison to energy-integrating detector CT for the workup of suspected acute pulmonary embolism, the use of photon-counting detector CT reduced radiation dosing by 48 percent, according to newly published research.
