CardieX said its new arterial health monitor, the CONNEQT Pulse, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The company said 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 incorporates CardieX's patented SphygmoCor technology, a provider of central blood pressure and non-invasive arterial waveform analysis for over 20 years.
Pulse's FDA clearance means the company's SphygmoCor technology can now be expanded to be used in decentralized clinical trials, remote patient monitoring, and for self-monitoring at home. The Pulse's vascular biomarker reporting enables clinicians and patients to have a more precise and personalized view of vascular health to better inform treatment options and superior outcomes.
Pulse's patented, non-invasive central aortic waveform technology measures key indicators of vascular health including central blood pressure, arterial stiffness, and additional vascular biomarkers, such as:
- Subendocardial viability ratio;
- Medical grade heart rate (similar to readings obtained in an ICU/hospital setting);
- Central pulse pressure;
- Augmentation pressure; and
- Augmentation index.
Pulse enables providers to monitor a patient's vascular biomarkers without requiring patients to leave the comfort of their homes, as well as enabling clinical trial managers to remotely manage trial participants without having them travel to a clinical trial site.
The FDA's clearance of the Pulse democratizes CardieX's market leading SphygmoCor technology by bringing deep vascular insights and clinically relevant heart health metrics to market at a price point that is now affordable to all.
Doctors can prescribe Pulse to patients who need to monitor their heart health. Patient data automatically syncs to the CONNEQT Patient Management Portal (CPMP), a cloud-based HIPAA-compliant patient management tool – which allows health care professionals to remotely monitor a patients' arterial health. In addition, consumers and patients can access deep arterial health insights, as well as coaching, lifestyle programs, and other health tools, through the CONNEQT app.
