Helius, a neurotech company, announced that the U.S. Food and Drug Administration has completed its review of the its request for De Novo classification and 510(k) clearance of the Portable Neuromodulation Stimulator (PoNS™) device and has declined the company's request. The company's CEO Phil Deschamps joined Cheddar to discuss how Helius will regroup after the defeat and submit a new request.