The FDA granted a second 510(k) clearance this week to CareTaker, a Charlottesville, Virginia connected medical device company. CareTaker's device of the same name is a wearable, connected blood pressure and heart rate sensor that originally received clearance this time last year.
“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, a professor of medicine at Johns Hopkins School of Medicine and president emeritus of the American Telemedicine Association, said in a statement when the device received its initial clearance. “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 is worn on the wrist with a cuff that's looped over the index finger. The device measures blood pressure and heart rate continuously and sends the data to an Android phone or tablet, or directly to a hospital via cellular networks. The device can also be used as a wearable hub for collecting and displaying (on the tablet screen) data from other connected devices including glucometers, weight scales, thermometers, and spirometers. The newest clearance allows the device to be used without first being calibrated with a traditional upper arm blood pressure cuff.
"The expanded FDA clearance for multi-parameter vital signs monitoring and use without the need for manual calibration are clear differentiators for the CareTaker wireless monitoring platform," Jeff Pompeo, president and CEO of Caretaker Medical, said in a statement. The CareTaker sets a new standard in continuous BP and vitals monitoring in terms of patient comfort and mobility as well as clinician productivity and automated workflow."
This is not the end of the regulatory road for the company. According to its website, CareTaker is capable of measuring several other vital signs once it's approved by the FDA to do so, including respiration rate, Sp02, temperature, and arterial stiffness.