cliexa-Protocols, web-based disease management system is a member of cliexaTM family of products which is a data and algorithm hub. It provides decision support to physicians and other healthcare providers during the treatment process and optimizes treatment methods based on evidence-based knowledge and data.
cliexa-Protocols has started as a pilot program, developed and evolved in early 2014. It was recognized and initiated letter of intents by multiple healthcare provider firms as well as specialty pharma focusing on Hyponatremia and Hep C treatments.
In December 2013, CN4CE Inc. has submitted a 513(g) application for cliexa-Protocols. After reviewed by FDA, FDA confirmed that cliexa-Protocols Disease Management System is a medical device as defined in section 201(h) of the Act.
On May 10, 2016, cliexa-Protocols has received a confirmation from FDA for 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.