Imaging Diagnostic Systems, Inc.
This article was originally published in The Gray Sheet
Executive SummaryPrivate equity financing provides $25 mil. funding commitment from an institutional investor. The developer of the CTLM laser-based breast imaging device, designed to aid in the diagnosis of breast abnormalities without using breast compression or x-rays, plans to use the proceeds from the financing "for the ongoing clinical programs, product development, working capital and general corporate purposes," the firm states. The device utilizes laser technology and computed algorithms that create "contiguous cross-sectional slice images of the breast." Data from ongoing clinical trials at two sites are to be submitted to FDA in "late summer or early this fall," IDS says. The funding commitment provides the flexibility to draw upon the capital when needed, the firm notes
You may also be interested in...
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.