Technology | Wearable Sensors | May 12, 2016

FDA Approves CareTaker Wireless Remote Patient Monitor

Device offers continuous non-invasive blood pressure and heart rate monitoring using patented finger cuff technology

CareTaker Medical, wireless remote patient monitor, continuous blood pressure, heart rate, FDA clearance

May 12, 2016 — CareTaker Medical announced that the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for the company's Wireless Continuous Non-Invasive "Beat-by-Beat" Blood Pressure ("cNIBP") and Heart Rate Monitor. The device is based on patented Finger Cuff technology. 

The wearable CareTaker monitor enables uninterrupted wire-free and electrode-free vital signs monitoring throughout the full mobile continuum of care; within the clinic and hospital, during patient transport and remotely after patient discharge.  Using a comfortable, low-pressure finger cuff, CareTaker's patented Pulse Decomposition Analysis technology non-invasively measures continuous beat-by-beat blood pressure with accuracy exceeding Association for the Advancement of Medical Instrumentation (AAMI) requirements. The device also measures heart rate as accurately as a three-lead electrocardiogram (ECG) for remote display on the CareTaker secure Web portal or other wireless devices.

Historically, most continuous beat-by-beat blood pressure measurements require an invasive arterial catheter or complex equipment, and have therefore been used mainly in critical care settings. The CareTaker cNIBP technology delivers ICU-quality continuous measurements without intrusive catheters or cumbersome wires, giving clinicians the ability to identify hemodynamic deterioration trends early, allowing more time for intervention while providing a 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. The system’s onboard cellular and Bluetooth communication capabilities allow for simple setup and deployment as well as seamless integration with other devices, remote patient monitoring platforms and hospital electronic medical record systems.

"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 Jay Sanders, M.D., 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 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."

For more information: www.caretakermedical.net

Related Content

Biotronik, BioMonitor 2 implantable cardiac monitor, BioInsight clinical study, first patients enrolled
News | Implantable Cardiac Monitor (ICM)| January 20, 2017
Biotronik has enrolled the first patients in the BioInsight clinical study evaluating the safety and feasibility of...
LindaCare, expansion, remote patient monitoring, CIEDs, cardiac implantable electronic devices, United States
News | Remote Monitoring| January 18, 2017
LindaCare announced that it will open a new customer support facility in Connecticut to support growing interest in...
Frost & Sullivan, 18 technologies, growth opportunities, global healthcare, information technology, 2025
News | Information Technology| January 16, 2017
Frost & Sullivan has released a new report, “Vision 2025 – Future of Healthcare,” part of the company’s Advanced...
smartphone apps, cardiovascular health, Stanford University study, patient self-reporting, population health
News | Population Health| January 04, 2017
In a study published online by JAMA Cardiology, researchers from Stanford University assessed the feasibility of...
cybersecurity of ICDs, cyber security of medical devices

The FDA has concerns about the cybersecurity of implantable medical devices with wireless connections for patient monitoring or adjustments to how the device functions. Changing the function of an implantable cardioverter defibrillator (ICD) using wireless access to the device could present a major patient safety issue.

News | Information Technology| December 29, 2016 | Dave Fornell
As wearable and implantable patient monitoring or therapy devices become more sophisticated with advanced wireless co
terahertz imaging, wearable scanning device, Tokyo Institute of Technology, Nature Photonics

Terahertz imaging of a human hand using arrays of carbon nanotubes: (left) human hand inserted into the imaging device, and (right) resulting scan of the human hand.

News | Wearable Sensors| December 13, 2016
Scientists at Tokyo Institute of Technology have developed a portable and wearable terahertz scanning device for non-...
Corsens Medical, Corsens Cardiac Monitor, FDA 510(k) clearance
Technology | Patient Monitors| December 08, 2016
Corsens Medical Ltd. announced that it has received clearance for a Pre-Marketing Notification (510(k)) with the U.S....
Boston Scientific, HeartLogic Heart Failure Diagnostic Service, MultiSENSE trial data, AHA Scientific Sessions 2016
News | Heart Failure| November 18, 2016
Boston Scientific recently announced results from the first clinical trial evaluating the performance of the HeartLogic...
smartphone application, heart attack detection, University of Turku Finland
News | Remote Monitoring| October 28, 2016
A smartphone application developed by researchers at the University of Turku, Finland, can detect myocardial infarction...
iSmartweaR, smart clothing, jIndustrial Technology Research Institute, ITRI, wearable heart monitoring

An example of an iSmartweaR shirt that can monitor patient vital signs without the need for electrode wires.

News | Wearable Sensors| October 24, 2016
October 24, 2016 — Conventional smart clothing uses conductive fibers or rubber as sensing electrodes, and cardiac el
Overlay Init