Caretaker Medical announced that it received FDA 510(k) clearance for four new hemodynamic parameters for its VitalStream platform.
Charlottesville, Virginia-based Caretaker’s wearable, wireless, non-invasive VitalStream platform now has clearance to monitor cardiac output, stroke volume, heart rate variability and left ventricular ejection time.
According to a news release, the latest regulatory nod marks the company’s fifth FDA clearance for VitalStream, which it designed 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 measurements are built on Caretaker’s proprietary pulse decomposition analysis (PDA) waveform analysis technology, which uses a finger sensor to measure continuous, cuffless blood pressure and hemodynamics. VitalStream offers beat-by-beat data for clinicians to use in identifying patient deterioration earlier so they can intervene earlier and optimize treatment decisions.
VitalStream’s data can be streamed remotely to the company’s mobile app or secure cloud portal and it can be integrated into other monitoring systems and electronic medical records (EMRs) with the company’s FDA-cleared software interface. The company said the platform can reduce risk and cost, increase patient mobility and enable clinicians and patients to benefit from comfortable, continuous, high-acuity monitoring.
The company said that VitalStream is immediately available in the U.S. and it expects to make the platform available in Europe and Asia later this year.
“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,” Caretaker Medical CEO Jeff Pompeo said in the release. “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.”
