Australian health technology company CardieX has received the US Food and Drug Administration (FDA) 510(k) approval for its new arterial health monitor, CONNEQT Pulse.
CONNEQT Pulse is designed to provide the measurements of both brachial blood pressure and central blood pressure in addition to multiple other vascular health biomarkers.
It features CardieX’s patented SphygmoCor technology for central blood pressure and non-invasive arterial waveform analysis and can be used at home, POC, and clinical trial sites.
The vital signs monitor provides insights into heart health, which was previously available only in hospitals, research institutions and clinical trials, but not in traditional blood pressure monitors.
Pulse includes the same pulse wave analysis technology that cardiologists use for estimating the arterial pressure at the aorta, said the company.
CardieX Group CEO and CONNEQT co-founder Craig Cooper said: “CONNEQT Pulse’s 510(k) clearance by the FDA marks a major milestone in the field of cardiovascular health management.
“We are thrilled to offer individuals with hypertension and other vascular diseases an innovative new way to monitor their arterial health at home with the same tools the country’s top cardiologists use in their research facilities and clinics.
“This technology has the potential to truly revolutionise the way hypertension and vascular disease is diagnosed and managed in the future.”
CardieX said that the FDA approval of CONNEQT Pulse will expand the use of its SphygmoCor technology into decentralised clinical trials, remote patient monitoring, and self-monitoring at home.
Pulse offers vascular biomarker reporting to help clinicians and patients have a precise and personalised view of vascular health, to enhance treatment options and outcomes.
The health monitor features a patented, non-invasive central aortic waveform technology that measures important indicators of vascular health.
It measures central blood pressure, arterial stiffness, and additional vascular biomarkers, such as subendocardial viability ratio, medical grade heart rate, central pulse pressure, augmentation pressure, and augmentation index.
The device automatically transmits patient data to CONNEQT Patient Management Portal (CPMP), a cloud-based HIPAA-compliant patient management tool.
It allows consumers and patients to access deep arterial health insights, along with coaching, lifestyle programs, and other health tools, through the CONNEQT app, said CardieX.
