FDA Clears Caretaker Medical’s Patient Monitor for Continuous Hemodynamic Parameters
Caretaker Medical, a digital health provider of wireless patient monitoring technologies, has received FDA 510(k) clearance for four new continuous hemodynamic parameters, adding cardiac output, stroke volume, heart rate variability, and left ventricular ejection time to its VitalStream non-invasive patient monitoring platform.
The VitalStream wireless wearable is built for high-acuity, ICU-grade hemodynamic monitoring without limiting patient mobility or requiring invasive catheters and wires that tether patients to bedside equipment.
The new advanced hemodynamic measurements are built on Caretaker’s proprietary Pulse Decomposition Analysis waveform analysis technology which uses a simple and comfortable Finger Sensor to measure continuous cuffless blood pressure and hemodynamics to eliminate “blind-spots” between manual spot-check measurements and enable high-acuity, uninterrupted monitoring across the continuum of care, including critical-care, sub-acute, emergency, medical-surgical floors, hospital-at-home, and other environments. VitalStream provides actionable, beat-by-beat data to help clinicians identify patient deterioration earlier, intervene earlier, and optimize treatment decisions such as whether and when to administer fluids, drugs, or therapies.
Continuous hemodynamic monitoring is performed to assess the impact that surgery, anesthesia or critical illness may have on a patient and to guard against adverse outcomes from hypotension or hypoperfusion. Post-operative hypotension is common and strongly associated with major vascular events. Caretaker Medical’s wireless and non-invasive advanced hemodynamic parameters are aimed at reducing risk and cost, increase patient mobility, and enable clinicians and patients to benefit from comfortable, continuous, high-acuity monitoring.
“Post-operative hypotension is a frequent occurrence that is unrecognized with intermittent spot checks-based monitoring in most hospital ward patients. Myocardial injury is strongly associated with hypotension in this period of recovery from surgery,” says Ashish Khanna, MD, associate professor, vice chair for Research, Department of Anesthesiology, Section on Critical Care Medicine at Wake Forest University School of Medicine Center. “With FDA Cleared wireless wearable technology we can now continuously monitor a patient’s changing hemodynamic status through surgery and their entire hospital stay. The ability to noninvasively see beat-by-beat blood pressure and hemodynamic deterioration in real time allows us to make early interventions and potentially improve outcomes.”
VitalStream’s continuous hemodynamics, waveforms, and vital sign data can be streamed remotely to the company’s mobile app or secure cloud portal or integrated into other monitoring systems and EMR’s with their FDA-cleared software interface SDK’s.
“This FDA Clearance adding advanced hemodynamics to our wireless VitalStream platform reaffirms our strategy and leadership in developing new ICU-grade parameters never before available in one mobile device,” says Jeff Pompeo, Caretaker Medical’s CEO. “We are proud to offer the world’s only wireless wearable to be clinically validated and FDA cleared to measure continuous Blood Pressure, Cardiac Output, and other Hemodynamic parameters continuously, non-invasively, and wire-free. With VitalStream’s disposable Finger Sensor, 30-second setup time and intuitive workflow to boost nurse productivity, there is simply no reason for clinicians to rely on intermittent, spot-check measurements with ‘blind spots’ that miss critical clinical insights or endure wires and hoses that tether patients to bedside equipment.”
Caretaker’s VitalStream provides hospitals, clinicians, and patients thousands of “beat-by-by-beat” insights per minute that can lead to early interventions and reduced complications, automating data collection and reporting for improved nurse productivity and staffing, and enabling faster patient transition to lower cost beds without compromising monitoring safety.
The VitalStream wireless hemodynamic monitor is available immediately in the U.S. directly from the company and its distribution partners.
