CareTaker Medical’s heart rate and blood pressure monitor receives FDA clearance
Charlottesville-based CareTaker Medical announced Tuesday that its heart rate and blood pressure monitor has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
According to the FDA’s website, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.
The CareTaker monitor uses a low-pressure finger cuff to measure blood pressure and heart rate for display on the CareTaker web portal or other wireless devices.
“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,” Dr. Jay Sanders, adjunct professor of medicine at Johns Hopkins School of Medicine and president emeritus of the American Telemedicine Association, said in a statement. “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.”
CareTaker Medical is a wireless medical device firm, which aims to develop remote patient monitoring solutions that improve outcomes, increase clinician productivity, and maximize patient compliance and comfort.