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.
Study Assesses Lung CT-Based AI Models for Predicting Interstitial Lung Abnormality
September 6th 2024A machine-learning-based model demonstrated an 87 percent area under the curve and a 90 percent specificity rate for predicting interstitial lung abnormality on CT scans, according to new research.