CardieX Limited announce that following its recent submission to the US Food and Drug Administration (FDA) for the CONNEQT Companion App (App), the Company has been advised by the FDA that the App has been classified as a non-device MDDS, rather than an accessory to a Class II Medical Device. As a result, the Company now has the flexibility to launch the App, subject to FDA-clearance of the CONNEQT Pulse.
The MDDS classification of the CONNEQT App provides the Company with flexibility not only when it comes to launching the application, but it also de-risks the pathway to market for CardieX's upcoming new devices, given there will not be a requirement for a full separate submission to the FDA for the consumer companion App.