WESTON, June. 25, 2021 | NIKAO is proud to announce that our partner DermaSensor has been granted FDA Breakthrough Device Designation. DermaSensor Inc., a health technology company designing non-invasive tools to better equip primary care providers for skin cancer checks, has been awarded breakthrough device designation by the FDA. The designation ensures close collaboration with and expedited review by the FDA, and provides formal acknowledgement that the DermaSensor device is addressing life-threatening disease and is expected to offer improved effectiveness compared to currently available products. Indeed, the company expects its product to be the first ever FDA cleared or approved skin cancer detection device for primary care providers Nikao will is the exclusive developer and manufacturer of the Proprietary Technology that utilizes light-emitting technology to evaluate potentially cancerous lesions on the surface of a patient’s skin. “Our vast experience in Medical Devices, Product Development, Design for Manufacturing, FDA Submissions, and Light-Emitting Technologies, made this partnership a perfect match,” said Edwin Aguilera, Founder of Nikao, Inc.
DermaSensor was founded in 2009 by healthcare investor and serial entrepreneur Dr. Maurice Ferré, who was previously the CEO of MAKO Surgical, which sold to Stryker for $1.65 billion. Ferré, son of the former Miami mayor, is also chairman and CEO of Insightec, a brain health company founded in Israel; co-founder of Miami-based Fastrack Institute; and on the board of Endeavor Miami, an organization that supports high-impact entrepreneurship.
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