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.
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Stroke MRI Study Assesses Impact of Motion Artifacts Upon AI and Radiologist Lesion Detection
July 16th 2025Noting a 7.4 percent incidence of motion artifacts on brain MRI scans for suspected stroke patients, the authors of a new study found that motion artifacts can reduce radiologist and AI accuracy for detecting hemorrhagic lesions.