The US Food and Drug Administration (FDA) has granted 510(k) clearance for CardieX’s CONNEQT Pulse, a new arterial health monitor.
CONNEQT Pulse has been designed for vital signs monitoring for use at home, by clinicians and in clinical trials.
It provides measurements of the brachial and central blood pressure along with many other vascular health biomarkers.
The device uses the company’s patented SphygmoCor technology for the analysis of central blood pressure and non-invasive arterial waveform.
It comprises the same pulse wave analysis technology used by cardiologists for predicting arterial pressure at the aorta.
CONNEQT Pulse provides vascular biomarker reporting to enable clinicians and patients to have a precise and personalised view of vascular health. This better informs treatment options and superior outcomes.
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.
“At launch, there won’t be any other vital signs monitor that provides the level of features, personalisation or vascular health insights that will be available on the Pulse.”
The company stated that the FDA approval of CONNEQT Pulse has expanded the use of its SphygmoCor technology in remote patient monitoring, decentralised clinical trials, as well as self-monitoring at home.
CONNEQT Pulse features a non-invasive, patented central aortic waveform technology which measures the important indicators of vascular health such as arterial stiffness and central blood pressure.
It also measures other vascular biomarkers such as central pulse pressure, augmentation index, subendocardial viability ratio, augmentation pressure and medical-grade heart rate.
CONNEQT Pulse automatically transmits patient data to a cloud-based HIPAA-compliant patient management tool – CONNEQT Patient Management Portal.
This allows healthcare providers to remotely monitor the arterial health of a patient.