cliexa-Protocols Disease Management System is cleared by FDA Regulatory Requirements

DENVER - May 18, 2016 - PRLog -- cliexa-Protocols web-based disease management system is a member of cliexa^TM  family of products which is a data and algorithm hub that provides decision support to physicians and other healthcare providers during the treatment process to optimize the treatment methods based on evidence-based knowledge and data. cliexa-Protocols has been a pilot program that has started to be developed and evolve in early 2014, which was recognized and initiated letter of intents with multiple healthcare provider firms as well as specialty pharma, starting with Hyponatremia and Hep C treatments.

In December 2013, CN4CE Inc. has submitted a 513(g) application regarding to the regulatory requirements which might be applicable to cliexa-Protocols. After reviewed by FDA, it has been confirmed that cliexa-Protocols Disease Management System is a medical device as that term is defined in section 201(h) of the Act. However, based on the information provided, FDA determined cliexa-Protocols as a mobile medical application.

As of May 10, 2016, cliexa-Protocols has received a confirmation from FDA along with the 513(g) application as cliexa-Protocols will NOT be enforced any regulatory requirements under applicable provisions of the Section 513(g) Act, including premarket notification, and its implementing regulations, in accordance with the Mobile Medical Applications Guidance (http://www.fda.gov/downloads/MedicalDevices/.../UCM263366...).

This has been another major milestone for cliexa^TM  family of products to implement pilot projects for multiple diseases that have been determined by CN4CE staff.