Caretaker Medical has secured approval from the US Food and Drug Administration (FDA) for its next-generation wireless blood pressure and haemodynamic monitoring platform called VitalStream.
The company has designed the VitalStream to avoid monitoring gaps associated with intermittent spot-check hemodynamic and vital sign measurements.
VitalStream, which uses a low-pressure finger sensor, is a non-invasive alternative to A-lines and arterial catheters.
The wireless platform is said to expand the firm’s clinically validated PDA waveform analysis technology and AI algorithms for the measurement of blood pressure and hemodynamic parameters with every heartbeat.
The new platform offers advanced haemodynamics, automated NEWS/MEWS early warning scores, higher resolution data and waveforms, and ultra-fast 30-second auto-calibration and setup time,
According to the company, VitalStream also provides streamlined clinical workflow, more data connectivity options and a smaller wearable form factor.
It helps to deliver an uninterrupted stream of real-time data, which eliminates blind spots between manual spot-check measurements without restricting patient mobility.
The platform facilitates ICU-grade patient monitoring at all points of care to offer clinicians streaming patient data for early indications of patient deterioration, quicker life-saving interventions, and better treatment decisions.
Caretaker Medical’s mobile app or secure cloud portal enables to remotely stream haemodynamics, waveforms, and vital sign data provided by VitalStream.
The company’s previous-generation beat-by-beat blood pressure and vital signs monitor is currently used by more than 150 global clinical customers across the full continuum of care, including OR, ICU, ER, Covid-19, infusion, sleep lab, neuropsych, pharma drug trials, and remote hospital-at-home.
Caretaker Medical CEO Jeff Pompeo said: “This is our fourth FDA Clearance expanding our wireless platform and enhancing our core continuous waveform technology and artificial intelligence algorithms.
“VitalStream sets a new standard in beat-by-beat hemodynamics in terms of accuracy, cost, simplicity of use, patient comfort, and streamlined workflow.
“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.”
The company added that it making available the VitalStream wireless hemodynamic monitor immediately in the US. The monitor is expected to be launched in Europe and Asia next year.
