CardieX Ltd (ASX:CDX) is trading higher after its CONNEQT companion app, which links up to its new dual blood pressure monitoring device, received a classification update from the Food and Drug Administration (FDA).
The key regulatory body has greenlit the app as a non-device medical device data system (MDDS), as opposed to an accessory to a Class II medical device.
This means that CardieX is approved to press launch on the companion app, so long as the FDA clears its CONNEQT Pulse device.
The health tech stock says the MDDS classification gives it increased flexibility — not only when it comes to launching the application, but also for de-risking the pathway to market for CardieX’s upcoming new devices.
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 has produced a positive response from investors with shares up as much 21% in the first hour of ASX trading to A$0.375.
Let’s CONNEQT
CardieX's CONNEQT app is part of a new digital ecosystem for both 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-based heart health vital signs monitoring system, that measures central blood pressure, arterial waveforms and other arterial parameters based on the 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 complete suite of arterial diagnostics.
It will also incorporate health coaching, patient record sharing, and remote patient monitoring features for future clinical use.