FDA grants 510(k) clearance to CareTaker Medical’s blood pressure and heart rate monitor
The FDA granted a 510(k) clearance for CareTaker Medical’s wireless continuous non-invasive “beat-by-beat” blood pressure and heart rate monitor.
The monitor uses the company’s finger cuff technology to continuously measure blood pressure and heart rate even when people are sleeping.
CareTaker Medical noted in a news release that many previous “beat-by-beat” monitors have required an invasive arterial catheter or complex equipment and been used mainly in critical care settings. However, this monitor does not require catheters or wires.
“CareTaker is a real game changer, allowing physicians to remotely monitor medical-grade Continuous Blood Pressure and Heart Rate from anywhere, using only a patient friendly-finger cuff” Jay Sanders, MD, an adjunct professor at the Johns Hopkins school of medicine and president emeritus of the American Telemedicine Association, said in a news release. “Until now, most clinicians have had to settle for intermittent ‘point-in-time’ Blood Pressure measurements using bulky arm cuffs, which can produce misleading results due to the influence of many factors such as movement, posture, anxiety, or caffeine. In remote monitoring settings, the ability to gather continuous Blood Pressure and vital sign data from such an integrated easy-to-use device will provide better information and improve patient compliance while reducing cost and workload.”