- The US FDA has classified CardieX’s (CDX) CONNEQT Companion app as a Medical Device Data System (MDDS)
- The app will work in line with the CONNEQT Pulse device, which is a dual blood pressure management system
- CardieX says the classification reduces risk for market entry of its other upcoming new devices, as they won’t require a full separate submission to the FDA
- Subject to FDA-clearance of the CONNEQT Pulse, the company will now be able to launch the app
- Shares are trading 14.5 per cent higher at 35.5 cents each at 12:25 pm AEST
CardieX (CDX) has made progress in launching its CONNEQT Companion app, after the US Food and Drug Administration (FDA) classified it as a Medical Device Data System (MDDS).
The app will work in line with the company’s CONNEQT Pulse device, which is a dual blood pressure management system.
Once the platforms are connected, patients will be able to manage a suite of arterial diagnostics. It will also include health coaching, patient record sharing, and remove patient monitoring features for future clinical use.
The classification reduces risk for market entry of its other upcoming new devices, as there will be no requirement for a full separate submission to the FDA for the consumer companion app.
Subject to FDA-clearance of the CONNEQT Pulse, CardieX will be able to launch the app.
Shares were trading 14.5 per cent higher today at 35.5 cents each at 12:25 pm AEST.