FDA clears vascular biometric monitor from CardieX

The Conneqt Pulse system. [Image courtesy of CardieX]CardieX announced today that it received FDA 510(k) clearance for its Conneqt Pulse vital signs monitor system.

Irvine, California-based CardieX designed Pulse for vital signs monitoring for use at home, by clinicians and in clinical trials. It provides measurements of both brachial blood pressure and central blood pressure, plus other vascular health biomarkers.

Pulse uses CardieX’s patented SphygmoCor technology for central blood pressure and non-invasive arterial waveform analysis. The system provides heart health insights previously only available in hospitals, research institutions and clinical trials, CardieX says. It uses the same pulse wave analysis technology used by cardiologists to predict arterial pressure in the aorta.

FDA clearance means CardieX can expand its SphygmoCor technology to use in decentralized clinical trials, remote patient monitoring and at-home self-monitoring. Its vascu…

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