Contact: CareTaker Medical, LLC, Charlottesville VA;
Jeff Pompeo, CEO (434) 409-1945
FDA Clears CareTaker® Wireless Patient Monitor For Continuous Non-Invasive Blood Pressure (“CNIBP”) and Heart Rate Monitoring using simple Finger Cuff Technology
Charlottesville, VA April 8, 2016 /PRNewswire -- CareTaker Medical, a pioneer in wireless remote patient monitoring devices, announced that the U.S. Food and Drug Administration has issued 510(k) clearance for the company’s Wireless Continuous Non-Invasive Blood Pressure (“cNIBP”) and Heart Rate Monitor, based on Finger Cuff technology.
The wearable CareTaker® monitor enables uninterrupted wire-free and electrode-free real-time vital signs monitoring throughout the full continuum of care, from clinic and hospital, to transport, and home monitoring after patient discharge. Using only a comfortable, low-pressure finger cuff, CareTaker’s patented Pulse Decomposition Analysis technology non-invasively measures continuous Beat-by-Beat blood pressure as accurately as an invasive arterial catheter, and measures Heart Rate as accurately as a 3-lead ECG for remote display on the CareTaker® secure web portal or other wireless devices.
Historically, most continuous “beat-by-beat” real-time Blood Pressure measurements have been invasive and costly, and therefore have been reserved for use in critical care settings. The CareTaker cNIBP technology delivers “ICU Quality” continuous measurements without intrusive catheters or cumbersome wires, giving clinicians the ability to recognize developing cardiopulmonary trends earlier with more lead time for intervention while providing a much more comprehensive view of a patient’s hemodynamic status. CareTaker’s comfortable finger cuff is gentle enough to be worn continuously, even during sleep, and usage is intuitive enough to ease the clinician’s workflow. Equally important, CareTaker’s onboard Cellular and Bluetooth communication capabilities make seamless integration with remote patient monitoring systems or hospital Electronic Medical Record systems possible.
“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” said Dr. Jay Sanders, MD, Professor of Medicine (adjunct) at Johns Hopkins School of Medicine and President Emeritus of the American Telemedicine Association. “Until now, most clinicians have had to settle for limited 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, gathering vital sign data from such a simple integrated device will improve patient compliance while reducing cost and workload.”
“CareTaker4 sets a new standard in continuous vital sign monitoring in terms of patient comfort, mobility, and clinical ease-of-use, in a low-cost wearable form factor” added Jeff Pompeo, CareTaker Medical’s CEO. “We’re pleased to have our first FDA clearance completed, as we continue to expand our patented technology and wireless platform to add additional features in the future, such as Respiration, Sp02, blood volume indication, and other cardiopulmonary measurements.”
About CareTaker Medical
CareTaker Medical, LLC is a Charlottesville, Virginia based wireless medical device firm focused on developing affordable, innovative, remote patient monitoring solutions that improve outcomes, increase clinician productivity, and maximize patient compliance without compromising patient comfort. More information is available at www.CareTakerMedical.net