Caretaker Medical Achieves FDA Clearance for VitalStreamART® : Expanding the Wireless VitalStream Platform to Deliver both Invasive and Non-Invasive Multimodal Continuous Hemodynamic Monitoring

CHARLOTTESVILLE, VA – December 19, 2025 – Caretaker Medical, the pioneer in continuous, noninvasive hemodynamic monitoring with its wireless VitalStream platform, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new VitalStreamART® Arterial Line Interface.

The introduction of VitalStreamART extends the VitalStream’s Wireless-Wearable platform to a complete multimodal solution, capable of delivering both noninvasive and minimally invasive continuous hemodynamic monitoring. This expansion allows clinicians to access continuous, high-fidelity hemodynamic data by choosing either a non-invasive Finger Sensor or an existing arterial line catheter without disposables. Both modalities are available on the same VitalStream device and utilize Caretaker Medical’s patented Pulse Decomposition Analysis (PDA™) Technology to ensure accuracy.

This multimodal capability ensures that every patient can now benefit from continuous insight into critical hemodynamic parameters, including Pressure, Volume, Cardiac Output (CO), Systemic Vascular Resistance (SVR), and Fluid Response, enabling clinicians to identify hidden shock earlier and better manage blood pressure (BP).

Advanced Hemodynamic Insight for All

VitalStreamART leverages the same clinically proven, continuous, beat-by-beat PDA™ data algorithms as the core VitalStream platform. This seamless integration provides clinicians with the flexibility to use a single, unified system across different patient monitoring needs—from noninvasive monitoring to utilizing the in-room arterial line interface in critical care settings.

“The FDA clearance of VitalStreamART underscores our commitment to providing universal access to advanced hemodynamic insights,” said Jeff Pompeo, CEO of Caretaker Medical. “By offering both noninvasive and minimally invasive continuous monitoring within one platform, we are breaking down barriers to deliver continuous hemodynamic data across all points of care. VitalStreamART now ensures that every patient, regardless of their current access or monitoring modality, can have the crucial volume, cardiac output, SVR, and Fluid Management data needed to identify hemodynamic instability, enabling faster intervention and personalized BP management. This is the future of proactive patient care.”

Leveraging Proprietary PDA Technology

The VitalStream platform is powered by Caretaker Medical’s proprietary Pulse Decomposition Analysis (PDA™) technology, which is recommended by the Anesthesia Patient Safety Foundation (APSF) for its ability to provide highly accurate, beat-by-beat blood pressure and hemodynamic measurements. This technology analyzes the pulse wave to derive a comprehensive set of hemodynamic parameters.

Clinical Impact: A Clinician’s Perspective

The new Art-Line interface is expected to have a significant clinical impact, particularly in settings where timely decision-making is required.

“The ability to transition from Caretaker’s noninvasive Finger Sensor to an Art-Line for continuous hemodynamic monitoring on a single platform without expensive disposables will streamline workflow and simplify data interpretation at multiple care points,” commented Dr. Damon Kuehl, Emergency Medicine Clinician at Carillion Clinic in Roanoke, Virginia. “The comprehensive hemodynamic profile—especially the continuous data on volume status and cardiac output— is a major leap in managing critical ill patients with precision . This tool will allow us to access immediate, high-fidelity insights that are essential for effectively identifying and treating both early signs of shock and guiding ongoing resuscitation in even the most challenging of patients.”

The VitalStreamART Arterial Line Interface is now available for ordering in the United States.

About Caretaker Medical

Caretaker Medical is a leader in continuous, blood pressure and hemodynamic monitoring, dedicated to developing innovative solutions that provide clinicians with vital, continuous physiological data for optimizing patient care. The company’s flagship VitalStream platform is setting new standards for continuous, beat-by-beat monitoring across the continuum of care, and serves as the foundation for our next generation of digital health and predictive capabilities.