Breast Cancer

First Module of CTLM Breast Imaging System Gets FDA Acceptance

Published in Women's Health Weekly, January 31st, 2002

Imaging Diagnostic Systems, Inc., (IMDS) has received a letter of acceptance from the U.S. Food and Drug Administration for Module 1 of its CTLM Breast Imaging System as part of the Premarket Approval process.

Module 1 contained a complete description of the CTLM system, its functional components and principles of operations. It also addressed safety issues related to the design of the CTLM system.

"This latest FDA development brings us closer to gaining marketing clearance and bringing this much-needed device to the market," said John d'Auguste, Imaging Diagnostic Systems president. "With this module approved, all efforts within the company are...

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Source: Women's Health Weekly (2002-01-31)

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