The Food and Drug Administration has notified U.S. Surgical thatit will allow the Norwalk, CT, company to continue to market itsAdvanced Breast Biopsy Instrumentation (ABBI) device under theproduct's existing 510(k) application. The FDA issued a
The Food and Drug Administration has notified U.S. Surgical that
it will allow the Norwalk, CT, company to continue to market its
Advanced Breast Biopsy Instrumentation (ABBI) device under the
product's existing 510(k) application. The FDA issued a warning
letter to U.S. Surgical last month, claiming that ABBI's 510(k)
application did not include an indication for breast biopsy (SCAN
6/19/96). U.S. Surgical denied the FDA's claims. The two sides
are in negotiations to resolve any remaining issues related to
ABBI advertising and labeling, according to the company.
Comparative AI Study Shows Merits of RapidAI LVO Software in Stroke Detection
February 6th 2025The Rapid LVO AI software detected 33 percent more cases of large vessel occlusion (LVO) on computed tomography angiography (CTA) than Viz LVO AI software, according to a new comparative study presented at the International Stroke Conference (ISC).
Study: Mammography AI Leads to 29 Percent Increase in Breast Cancer Detection
February 5th 2025Use of the mammography AI software had a nearly equivalent false positive rate as unassisted radiologist interpretation and resulted in a 44 percent reduction in screen reading workload, according to findings from a randomized controlled trial involving over 105,000 women.