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.

As of November 2010, IDSI has submitted a 510(k) application to the FDA. With this submission, the company moves forward in the process of seeking marketing clearance for its innovative breast imaging device, the CTLM system. The Company intends to pursue a rigorous clinical program to discover and commercialize the envisioned applications.

The company has received CE Marking, CMDCAS (Canada), Canadian License, UL listing, ISO 13485 certification, China SFDA and FDA export certification, enabling sales in international markets.