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FDA Breakthrough Device Received

Updated: Oct 13

Los Angeles, 2019


Niche Biomedical has received Breakthrough Device Designation from Food and Drug Association (FDA). This is a step forward in the company's mission to provide patients living with chronic conditions, novel neuromodulation techniques and devices, who up until now have had to resort to conventional medicine. This designation from the FDA is an acknowledgement of the advancements that Niche Biomedical devices can bring to the industry.


Niche Biomedical's device receiving this designation is focusing on indications that have no approved alternatives yet and could prove to be a remarkable addition to the neuromodulation medicine and device industry.

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Niche Biomedical Inc.

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