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Medical Devices / Submissions and Approvals

FDA Grants Clearance to QT Ultrasound for Breast Imaging Device

June 15, 2017
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QT Ultrasound has received FDA marketing clearance for its Transmission Wave Ultrasound breast scanner.

The scanner produces 360° images of the breast and eliminates the use of radiation and breast compression.

The breast scanner is not intended as a replacement for screening mammography.

The company has initiated a clinical trial program to determine its efficacy. — Cynthia Jessup

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