CardieX Limited has announced that its new arterial health monitor, the CONNEQT Pulse has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
According to a release by PR Newswire, Pulse is the only vital signs monitor targeted at home, clinician, and clinical trial use that provides measurements of both brachial blood pressure (the pressure at your arm) and central blood pressure (the pressure at your aorta/heart) in addition to multiple other vascular health biomarkers. Pulse provides heart health insights previously only available in hospitals, research institutions and clinical trials reporting on a panel of heart and vascular biomarkers not available in traditional blood pressure monitors. Pulse uses the same pulse wave analysis technology used by cardiologists to predict arterial pressure where it matters most: at the aorta, the release stated.
"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, personalization, or vascular health insights that will be available on the Pulse. This technology has the potential to truly revolutionize the way hypertension and vascular disease is diagnosed and managed in the future."
The Pulse is a unique vital signs monitor designed for use in clinical trials, clinical settings and homes, the release stated. It measures various vascular health biomarkers along with brachial blood pressure and central blood pressure (at the heart/aorta), providing heart health information previously only available in hospitals and research institutions. The technology reports on a panel of heart and vascular biomarkers that traditional blood pressure monitors cannot detect. Pulse utilizes pulse wave analysis technology, similar to that used by cardiologists, to predict arterial pressure accurately at the aorta.
The special FDA clearance will allow the company's technology to be used in decentralized clinical trials, remote patient monitoring, and for self-monitoring at home. Pulse's reporting enables clinicians and patients to have a more precise and personalized idea of their vascular health, thereby better informing both parties on treatment options, the release stated. Pulse monitors central blood pressure, arterial stiffness, and other vascular biomarkers such as subendocardial viability ratio, medical grade heart rate, central pulse pressure, augmentation pressure and augmentation index, the release stated.
Patient data automatically syncs to the CONNEQT Patient Management Portal, a cloud-based, HIPAA-compliant patient management tool. That allows health care providers to monitor patient's arterial health remotely. Additionally, remote monitoring options will allow clinical trial managers to remotely manage trial participants without having them travel to the clinical trial site.
