FDA Clereance

Echolight obtains FDA Clereance.

It’s a great pleasure to announce that Echolight has received the 510(K) approval from the FDA –  U.S. Food and Drug Administration, the governing body that regulates the trade of medical devices within the US market, for its EchoS system and the final authorization to start marketing and selling it since last November.

This new important achievement and recognition obtained internationally, is a fundamental element for the diffusion of the innovative R.E.M.S. technology (Radiofrequency Echographic Multi Spectrometry) worldwide, which thanks to its high levels of precision recognized by the scientific community, in combination with the complete absence of ionizing radiation and proven ease of use, will allow EchoS to be effectively used for the early diagnosis of the osteoporosis and bone health assessment in primary care.

EchoS, entirely developed in Italy, and already marketed in over 30 countries, provides the medical community with the next generation of bone densitometry, capable of evaluating the bone status to prevent fractures and constantly monitor the parameters for disease analysis, aimed at raising the quality of life worldwide.