1. FDA approval will take place between April 19th and April 20th.
2. “Helius is very pleased by CMS’ commitment to providing Medicare beneficiaries nation-wide with expedited access to new, FDA-designated breakthrough devices, like our PoNS device,” said Dane Andreeff, Interim President and Chief Executive Officer of Helius. “If our request for de novo classification and clearance of the PoNS device is granted by the FDA, the new MCIT rule provides the opportunity to potentially obtain immediate, nation-wide Medicare coverage for four years following its commercial launch. We look forward to working with CMS to obtain more information and express our interest in MCIT, with the goal of providing the approximately 60 million Americans enrolled in Medicare with improved access to the PoNS device.”
3. In short, the start button flashes, maybe it's glows too... |
