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.
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.
Study Shows Enhanced Diagnosis of Coronary Artery Stenosis with Photon-Counting CTA
July 10th 2025In a new study comparing standard resolution and ultra-high resolution modes for patients undergoing coronary CTA with photon-counting detector CT, researchers found that segment-level sensitivity and accuracy rates for diagnosing coronary artery stenosis were consistently > 89.6 percent.
FDA Expands Approval of MRI-Guided Ultrasound Treatment for Patients with Parkinson’s Disease
July 9th 2025For patients with advanced Parkinson’s disease, the expanded FDA approval of the Exablate Neuro platform allows for the use of MRI-guided focused ultrasound in performing staged bilateral pallidothalamic tractotomy.