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FDA to hold medical software hearing
The Food and Drug Administration and the National Library of Medicinehave scheduled a workshop in September to discuss the FDA's regulationof medical software. The meeting is intended to clarify confusionregarding requirements that apply to medical
The Food and Drug Administration and the National Library of Medicinehave scheduled a workshop in September to discuss the FDA's regulationof medical software. The meeting is intended to clarify confusionregarding requirements that apply to medical software devicesand accessories, according to the agency.
The workshop is scheduled for Sept. 3 and 4 at the NationalInstitutes of Health, Natcher Conference Center, 45 Center Dr.,Bethesda, MD. For more information contact Charles Furfine ofthe FDA's Center for Devices and Radiological Health at 301/443-2536,ext. 16. Information related to the workshop can also be accessedon the FDA's World Wide Web home page at http://www.fda.gov.
Mammography Study Suggests DBT-Based AI May Help Reduce Disparities with Breast Cancer Screening
December 13th 2024New research suggests that AI-powered assessment of digital breast tomosynthesis (DBT) for short-term breast cancer risk may help address racial disparities with detection and shortcomings of traditional mammography in women with dense breasts.
Study Shows Merits of CTA-Derived Quantitative Flow Ratio in Predicting MACE
December 11th 2024For patients with suspected or known coronary artery disease (CAD) without percutaneous coronary intervention (PCI), researchers found that those with a normal CTA-derived quantitative flow ratio (CT-QFR) had a 22 percent higher MACE-free survival rate.
Can MRI-Based AI Bolster Biopsy Decision-Making in PI-RADS 3 Cases?
December 9th 2024In patients with PI-RADS 3 lesion assessments, the combination of AI and prostate-specific antigen density (PSAD) level achieved a 78 percent sensitivity and 93 percent negative predictive value for clinically significant prostate cancer (csPCa), according to research presented at the Radiological Society of North American (RSNA) conference.
Assessing MACE Risk in Women: Can an Emerging Model with SPECT MPI Imaging Have an Impact?
December 9th 2024In research involving over 2,200 women who had SPECT MPI exams, researchers found that those who had a high score with the COronary Risk Score in WOmen (CORSWO) model had a greater than fourfold higher risk of major adverse coronary events (MACE).
