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CDRH touts lack of application backlog
The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) announced this month that for the second year in a row, its premarket review program had no backlog of 510(k)s, premarket approval applications, or PMA supplements
The Food and Drug Administrations Center for Devices and Radiological Health (CDRH) announced this month that for the second year in a row, its premarket review program had no backlog of 510(k)s, premarket approval applications, or PMA supplements for fiscal year 1998.
Average total review time for 510(k) applications was 114 days an improvement over 130 in 1997 and 145 in 1996. Median review time for 510(k)s that cleared in fiscal year 1998 was 83 days. CDRH cleared 46 PMAs in 1998, according to the agency. The average review time of PMAs from submission to approval was roughly 12 months, 25% less than fiscal year 1997 and 50% less than fiscal year 1996. The median total time the CDRH took to clear PMAs in 1998 was about nine months.
The program attributed improved clearance times to more companies consulting with the FDA as they plan clinical studies. They also credited pilot management initiatives the CDRH implemented this year.
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.
Could a Newly FDA-Cleared C-Arm Device Bolster Efficiency for Interventional Radiologists?
April 22nd 2024In addition to advanced imaging quality and dose efficiency, the Philips Zenition 30 mobile C-arm device emphasizes personalized user profiles and automated customization to help reduce procedure time.
