Ann: FDA Update for CONNEQT Companion App, page-8

My understanding of the situation.

Up to today's notice, Cardiex had considered the CONNEQT App and the CONNEQT Pulse BP Monitor to be classified as Class II Medical Devices.

A Class II Medical Device needs FDA CLEARANCE - not a long process - unlike Class III devices that need FDA APPROVAL - but still requiring submission, time etc.

As of this notice, the FDA has classified the CONNEQT App as a Medical Device Data system, rather than a Class II Medical Device, and hence the App is not subject to FDA regulatory requirements.

Here's more on MDDSs from the FDA:
https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/medical-device-data-systems


The CONNEQT Pulse BP monitor still requires FDA CLEARANCE. We are waiting for Andon to lodge our application for its clearance.

14th April: