CardieX : subsidiary files key regulatory submission for CONNEQT companion app

CardieX Ltd (ASX:CDX) 's CONNEQT subsidiary has filed a key clearance submission for its eponymous smartphone application with the US Food and Drug Administration (FDA).

The consumer health company is developing the CONNEQT app, which, when paired with the CONNEQT Pulse device, is designed to be the world's first home-use dual blood pressure management system, powered by fellow CardieX subsidiary ATCOR's SphygmoCor ® blood pressure monitoring technology.

CONNEQT has filed a 510(k) premarket clearance form with the FDA, which essentially seeks to demonstrate its device is as safe and effective as one that is legally marketed.

The CONNEQT Pulse dual blood pressure monitor is in the final stages of regulatory documentation prior to FDA lodgement.

Seeking unique competitive advantage

Speaking to the move, CardieX group CEO Craig Cooper said: "This application is an exciting milestone for us as a company as we look back on our 20 years of FDA clearances dating back to our first device clearance in 2002.

"Our strategy and vision with CONNEQT has always been to bring medical-grade diagnostics to the consumer and it's for that reason that we are seeking FDA clearance for the CONNEQT App - unlike other health apps that are not paired to a medical device ecosystem.

"We strongly feel that this will be a unique and significant competitive advantage for us on launch."

Let's CONNEQT

The 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.

The company has completed all of its requirements for the Pulse device's FDA submission and this has been provided to the company's manufacturing partner, Andon, which is expected to facilitate the lodgement in the near term.

The CONNEQT App forms the hub of CONNEQT's device ecosystem.

Down the line, it will also pair with the CONNEQT Band, a smart wearable also featuring a range of patented health and wellness features focused on heart and arterial health, including a blood pressure monitoring PPG sensor powered by the SphygmoCor ® technology.

Work continues to develop the CONNEQT Band in concert with Fenda Technology and LifeQ.