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 vascular biomarker reporting enables a precise and personalized view of vascular health. This better informs treatment options and superior outcomes, CardieX said.
Doctors can prescribe Pulse to patients who need heart health monitoring. The data automatically syncs to the Conneqt patient management portal to help healthcare professionals monitor arterial health. Consumers and patients can also access deep arterial health insights, coaching, lifestyle programs and other health tools.
“Conneqt Pulse’s 510(k) clearance by the FDA marks a major milestone in the field of cardiovascular health management,” said Craig Cooper, group CEO of CardieX and co-founder of Conneqt. “This technology has the potential to truly revolutionize the way hypertension and vascular disease is diagnosed and managed in the future.”
