Caretaker Medical (Charlottesville, Virginia) has secured FDA clearance for its next-generation VitalStream wireless blood pressure and hemodynamic monitoring platform, the company said today.
The VitalStream wireless platform expands on the previously cleared Caretaker4 wireless patient monitor. The platform, according to the company, can measure blood pressure and hemodynamic parameters with every heartbeat. The result is an uninterrupted stream of real-time data that eliminates “blind spots” between manual spot-check measurements.
The VitalStream platform relies on a low-pressure finger sensor. Caretaker Medical is marketing it as a non-invasive alternative to A-lines and arterial catheters, enabling ICU-grade patient monitoring at all points of care.
“Accurate, non-invasive hemodynamic monitoring is certainly preferred to invasive A-lines in most patient populations. My use of the VitalStream monitor in the OR demonstrates compelling benefits in patient comfort, simplicity of use, and continuous, accurate, actionable data,” Dr. Karen Boretsky, assistant professor of anesthesia at Harvard Medical School, said in a Caretaker Medical news release.
Caretaker Medical CEO Jeff Pompeo said this is its fourth FDA clearance as it expands its wireless platform and boosts core continuous waveform technology and AI. “We’re delivering ICU-grade monitoring that surpasses the most stringent regulatory certifications and clinical accuracy validation requirements to help improve outcomes at all points of care.”