Regulatory Status

The CTLM® is not approved for sale in the USA. To qualify for permission to sell and market, IDSI must obtain United States Food and Drug Administration marketing clearance. An FDA submission is supported by extensive data, including pre-clinical and clinical trial data, as well as extensive literature to prove the safety and effectiveness of the device.

The company has received CE Mark, CMDCAS (Canada), Canadian License, UL listing and ISO 13485 certification.

CTLM® – Laser Breast
Imaging Without Compression

Imaging Diagnostic Systems, Inc. (IDSI) is a medical device company located in Fort Lauderdale, Florida, engaged primarily in the research, development, and marketing of a non-invasive breast imaging system. Learn more »

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