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Imaging Diagnostic Systems Inks Contrast Collaboration With Schering AG

This article was originally published in The Gray Sheet

Executive Summary

Imaging Diagnostic Systems expects to complete its modular PMA submission for the computer tomography laser mammography (CTLM) imaging system this summer as Schering AG begins a separate feasibility trial of the system with a new contrast agent

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Laser Mammography PMA To Be Refiled; Dense Breast Imaging Enhanced

Imaging Diagnostic Systems plans to resubmit a premarket approval application for the CTLM computed tomographic laser breast imaging system within the next two months

Laser Mammography PMA To Be Refiled; Dense Breast Imaging Enhanced

Imaging Diagnostic Systems plans to resubmit a premarket approval application for the CTLM computed tomographic laser breast imaging system within the next two months

IDS PMA accepted

Imaging Diagnostic Systems' CTLM computer tomography laser mammography imaging system PMA is deemed suitable for filing by FDA, the firm says June 18. The non-invasive device is intended as an adjunct to mammography to aid in breast cancer detection using 3-D cross-sectional images (1"The Gray Sheet" April 1, 2002, p. 28)...

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