Arterial health monitor CONNEQT Pulse gains FDA 510(k) clearance

Today, CardieX, an international health technology firm, revealed that its latest arterial health monitoring device, the CONNEQT Pulse, has been granted FDA 510(k) clearance. The gadget made its official debut earlier this year at CES 2023.

If the name CardieX sounds familiar, that’s because Mobvoi has a collaboration with Australian-based AtCor Medical Inc, a subsidiary of CardieX. To this end they brought a bunch of advanced insights about arterial and heart health to their TicWatch GTH Pro watch. CONNEQT is another subsidiary of CardieX.

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CONNEQT Pulse is different from your run-of-the-mill blood pressure monitor. Its claim to fame is that it uses arterial health technology to provide medical-grade heart health metrics from home. This means it can do much more than simply take a persons’ blood pressure.

The device has now received FDA 510(k) clearance. This refers to the process by which the U.S. Food and Drug Administration (FDA) grants marketing authorisation for a new medical device that is substantially equivalent to a legally marketed “predicate” device. This clearance essentially allows the manufacturer to market and sell the device in the United States.

Impressive range of abilities

The range of abilities of the CardieX blood pressure monitor is pretty impressive. The gizmo can capture a wide range of arterial health parameters such as arterial stiffness, central blood pressure (the blood pressure at your heart), and additional vascular biomarkers, such as:

• Subendocardial viability ratio;
• Medical grade heart rate (similar to readings obtained in an ICU/hospital setting);
• Central pulse pressure;
• Augmentation pressure; and
• Augmentation index.

All of this is based on CardieX’s FDA-cleared “gold standard” SphygmoCor central blood pressure technology. This is tech that has been in use for over two decades in various settings. CONNEQT Pulse is the first consumer blood pressure monitor that will incorporate SphygmoCor central aortic waveform technology.

With the CONNEQT smartphone app, users will have the ability to personalise and set the priority of the parameters displayed on Pulse. For instance, a patient with a high risk for Alzheimer’s disease may choose to prioritize the display of central pulse pressure and arterial stiffness.

The device will also let you connect to a physician for remote patient monitoring. Plus it can be used to alert doctors on early warning signs of subclinical cardiovascular disease.

No word yet on a potential price but the company says the selling price “will be “targeted at consumers, mass-clinician markets, and other significant healthcare channels.“ The device is not available for purchase just yet but you can register on the manufacturer’s website to be first in line when it hits retail.

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