CardieX Ltd (ASX:CDX) is trading higher after its companion app CONNEQT, which connects to its new dual blood pressure monitoring device, received a classification update from the Food and Drug Administration ( FDA).
The key regulator has approved the app as a non-device Medical Device Data System (MDDS), as opposed to an accessory of a Class II medical device.
This means that CardieX is allowed to press launch the companion app, as long as the FDA clears its CONNEQT Pulse device.
The health tech stock says the MDDS rating gives it increased flexibility, not only when it comes to launching the app, but also to reduce the risk of bringing CardieX’s new devices to market. .
Essentially, that’s because the company isn’t required to make a full, separate submission to the FDA for its consumer companion app.
The news produced a positive response from investors with shares up 21% in the first hour of ASX trading at A$0.375.
CardieX’s CONNEQT app is part of a new digital ecosystem for consumers and clinicians, all based on ATCOR’s existing FDA-cleared SphygmoCor® technology.
The CONNEQT app will integrate with the CONNEQT Pulse device, a new home heart health vital signs monitoring system, which measures central blood pressure, arterial waveforms and other arterial parameters based on SphygmoCor® technology used in the company’s other devices.
Once the Pulse device and app are connected, patients will have access to and be able to manage a full suite of arterial diagnostics.
It will also incorporate health coaching, patient record sharing and remote patient monitoring features for future clinical use.