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Acuson

This article was originally published in The Gray Sheet

Executive Summary

Files 510(k) with FDA for its AcuNav miniaturized ultrasound catheter Sept. 21. Inserted through the femoral artery, the catheter is designed to help visualize cardiac structures, blood flow and Doppler hemodynamics inside the heart "with diagnostic quality 100 percent of the time," the firm maintains. Licensed by Acuson from the Mayo Clinic in Rochester, Minnesota, the AcuNav combines "a high performance, digital ultrasound system with a catheter the size of a strand of spaghetti," the company says

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