U.S. Surgical of Norwalk, CT, has received an updated 510(k) clearancefor its ABBI breast biopsy system, which had been the subjectof Food and Drug Administration scrutiny last year (SCAN 6/19/96).FDA regulators claimed that ABBI's original 510(k) did
U.S. Surgical of Norwalk, CT, has received an updated 510(k) clearancefor its ABBI breast biopsy system, which had been the subjectof Food and Drug Administration scrutiny last year (SCAN 6/19/96).FDA regulators claimed that ABBI's original 510(k) did not allowthe company to market the device for breast biopsy applications,while U.S. Surgical claimed that it included breast biopsy datain the submission. The new 510(k), issued last month, resolvesthe dispute.
Breast MRI and Background Parenchymal Enhancement: What a Meta-Analysis Reveals
May 29th 2025Moderate or marked background parenchymal enhancement (BPE) reduces the sensitivity and specificity of MRI for breast cancer detection by more than 10 percent in comparison to scans with minimal or mild BPE, according to a new meta-analysis.
Lunit Unveils Enhanced AI-Powered CXR Software Update
May 28th 2025The Lunit Insight CXR4 update reportedly offers new features such as current-prior comparison of chest X-rays (CXRs), acute bone fracture detection and a 99.5 percent negative predictive value (NPV) for identifying normal CXRs.