Major FDA Reform Bill Becomes Law: Medical Device Overview

On 13-Dec (US Time), a major FDA reform bill became law!

http://www.natlawreview.com/article/major-fda-reform-bill-becomes-law-medical-device-overview

This has enormous implications for NTI specifically under: Section 3051 – Breakthrough Devices
which states that the FDA will expedite the development and provide priority review for, breakthrough devices:

"that offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or"

Device firms may request designation under this section and the FDA must respond within 60 days of the request.


This will allow a streamlined and expedited US market entry if FDA approval and review is expedited due to the nature of Mente's breakthrough status!


PS Thank you @Wise_One for making me aware of this.