Ann: Trading Halt, page-109

In a significant development in the fight against hypertension and vascular disease, the United States Food and Drug Administration (FDA) on Friday granted 510(k) clearance for the CONNEQT Pulse, a dual blood pressure monitor that provides both brachial and central blood pressure measurements along with arterial waveform analysis.This state-of-the-art medical device, developed by CONNEQT, a subsidiary of global health tech company CardieX, provides heart health insights previously only available in specialist doctors’ offices, hospitals, and research facilities. Powered by CardieX’s patented SphygmoCor® technology, which has been used for over two decades by leading hospitals and research facilities all over the world, the Pulse measures key arterial health indicators including brachial blood pressure (the blood pressure at your arm) and central blood pressure (the blood pressure at your heart), augmentation index (an indirect measure of arterial stiffness), and multiple other clinically relevant digital vascular biomarkers. The Pulse measures can be viewed by the patient and also transmitted to the patient’s physicians and care providers for assessment. Together, these indices provide a much more comprehensive and precise picture of vascular health than a traditional brachial home blood pressure monitor.“CONNEQT Pulse’s 510(k) clearance by the FDA marks a major milestone in the field of cardiovascular health management,” says Craig Cooper, CEO of CardieX, the parent company of CONNEQT Health. “We are thrilled to offer individuals with hypertension an innovative new way to monitor their arterial health at home in conjunction with their healthcare provider using the same tools the country’s top cardiologists use in their research facilities and clinics. This technology has the potential to truly revolutionize the way hypertension and vascular disease is diagnosed and managed in the future.”