CardieX CONNEQT Pulse heart health monitor now has FDA 510(k) clearance
CardieX has revealed that it has received FDA clearance for its new CONNEQT Pulse cuff-based vascular biomarker monitor. The granted 510(k) means that the company has demonstrated to the FDA that its gadget is effective and safe for use. Unveiled at CES 2023, the Pulse uses patented technology to enable you to measure a wide range of biometrics which cannot be monitored by a traditional blood pressure device, providing broader insight into your heart health.
CardieX suggests that it is the first gadget of its kind to market, measuring the blood pressure in your arm and the blood pressure at your heart, otherwise known as your central blood pressure. Plus, the Pulse can show arterial waveform analysis alongside other vascular biomarkers. The gadget has been designed for at-home use; you can use the CONNEQT app to view the data collected by Pulse, with the option to enable a physician to monitor your health remotely.
The insights provided by the gadget could help to show warning signs of hypertension, cardiovascular disease, Alzheimer's and kidney disease. CardieX expects the CONNEQT Pulse to launch in Q3 and plans to roll it out across many markets worldwide. It is unclear how much the device will cost at launch. You can sign up to join the waiting list for the gadget on the CONNEQT website.
Source(s)
