Italian Company Formed to Market CT Laser Mammography

Imaging Diagnostic Systems, Inc. (IDSI; Plantation, FL, USA), a developer of human laser optical imaging systems, has signed a multiyear exclusive distribution agreement with CTLM Italia, a new company formed to commercialize the computed tomography laser mammography (CTLM) breast imaging system.

CTLM Italia has a unique business model to accelerate market entry. Building on the previous commercial sales and IDSI clinical research sites in Italy, CTLM Italia has organized 14 sales locations into a network spanning the country. The group is supported by a centralized in-country marketing group, with administration, service, and local language collaterals.

Vito De Mitri, CTLM Italia managing director, stated, "We believe the time is right to bring the CTLM functional breast imaging technology to the women of Italy. We have seen the research done at Catholic University Hospital in Rome and the European Institute of Oncology [IEO] in Milan and we see that this promising new imaging modality can provide highly valuable information to doctors specializing in breast cancer.”

Imaging Diagnostic Systems is seeking U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for its system.

The CTLM system is designed to be used as an adjunct to mammography. The FDA has determined that the IDSI's clinical investigation is a non-significant risk
(NSR) investigational device study because it does not meet the definition of a significant risk (SR) device under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is the first patented breast imaging system that utilizes state-of-the-art laser technology and patented algorithms to create three-dimensional (3D) images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression.



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