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FDA approves Caretaker Medical’s VitalStream wireless platform (nsmedicaldevices.com)

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VitalStream received FDA approval for their wireless hemodynamic monitoring device in September 2021. The device is worn on the wrist and has a disposable cover that is worn on one finger of the same hand. Rather than periodically measuring vital signs, VitalStream provides continuous monitoring.
Critically ill patients' vital signs are measured through arterial lines, which require an invasive procedure and increases the risk of infections. VitalStream allows for accurate noninvasive hemodynamic monitoring. This information is transmitted into the EHR for prompt provider review.
Periodic vital sign checks may not reflect the overall trend of heart rate, blood pressure, and oxygenation. Continuous monitoring while in the hospital can help recognize clinical changes sooner than scheduled checks. Weller et al. (2018) found a significant reduction in the number of rapid response team (RRT) calls regarding patients' deterioration during hospital admission. The care team detected changes and could intervene before an emergency.
Vital signs are a universal standard for assessing patients' hemodynamic status. VitalStream provides a "no strings attached" solution for continuous vital sign monitoring for patients at home or in the hospital.

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- Reduced fall risk during admission (fewer cables connected to patient)
- Reduced risk for infection (non invasive monitoring)
- Immediate transmission for provider review
- Reduced human error during manual input of data
- Increased patient participation and awareness of condition

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My top 5 strengths: harmony, learner, discipline, responsibility, and relator.

My strengths will help the team by having a positive outlook during the learning and change process. I am dedicated to staying with a deadline and helping to keep the team accountable with the implementation. Being a relator and having harmony will help maintain positive team dynamics.

Carter- Communication is needed to discuss ideas in small taskforce meetings and to effectively present to the larger group in a clear and concise manner.
Daisy- A developer will value each team member's individual contribution and celebrate the differences they bring to the table.
Rose- Relator is helpful when assessing current workflows. It will be important to build relationships and trust with teams across the hospital system to help implementation of VitalStream technology.
Sheila- A strategic partner will help plan the initial phases of the program launch, but can see the larger picture with what themes to address before they become problems.
William- Implementing change is difficult, especially with something that has an impact on the entire organization. Woo will help win clinicians over and create rapport between the different teams involved in the project.

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VitalStream From Caretaker Medical - The New Standard in Wireless Patient Monitoring

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I think wireless hemodynamic monitoring provided by VitalStream is a huge improvement for patient access and safety. The device could be used in the home setting, allowing for automatic transmission of data for the provider to review. It could be used in the ICU as a replacement for arterial lines with a goal of reducing infections and excess invasive procedures. It would also help with the efficiency of charting in step-down or telemetry units. Depending on the cost to the hospital, I think this is a great addition to advance patient care. Phones, headphones, and keyboards are all now wireless- it seems fitting that hospitals adapt to the available technology and change to wireless where they are able.

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Weller, R. S., Foard, K. L., & Harwood, T. N. (2018). Evaluation of a wireless, portable, wearable multi-parameter vital signs monitor in hospitalized neurological and neurosurgical patients. Journal of Clinical Monitoring and Computing, 32, 945-951. https://doi.org/10/.1007/s10877-017-0085-0

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Source: Conn Hastings/Medgadget (Nov. 11, 2021)

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Source: Conn Hastings/Medgadget (Nov. 11, 2021)

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Conn Hastings/Medgadget
November 11, 2021

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Caretaker Medical, a company based in Virginia, developed the VitalStream wireless patient monitor, and the company recently announced that the device has received FDA clearance. The technology is intended to improve on traditional blood pressure cuffs that provide only a snap-shot of blood pressure data, while being an alternative, in many cases, over invasive arterial catheters that come with a variety of potential complications, including infections, and difficulties with insertion.

The VitalStream provides continuous, wireless monitoring of a variety of hemodynamic parameters and blood pressure, which is particularly important in patients at risk of dangerous hypotensive events. The device itself is worn on the wrist, and a disposable finger sensor delivers blood pressure readings and additional sensors measure ECG, SpO2, body temperature, and ETCO2.

Caretaker Medical reports that the system can be set up quickly, and provides rapid alerts of any abnormalities or dangerous events. Patients can wear the device while in a hospital, and then take it home for additional monitoring, if required. The data are streamed to an app, the cloud, or can be interfaced with hospital computer systems, and the system provides automated reporting.

See a video about the technology below.

Medgadget had the opportunity to speak with Jeff Pompeo, President and CEO at Caretaker Medical, about the technology.
Conn Hastings, Medgadget: Please give us an overview of the health impacts of high or low blood pressure.

Jeff Pompeo, Caretaker Medical: Your blood pressure is changing constantly - rising and falling as needed to circulate oxygenated blood to your organs - and it's greatly influenced by body movement, stress, heart rate changes and hemodynamic instability. Although long-term high blood pressure (hypertension) is associated with increased health risks, a far bigger concern is a sudden drop in blood pressure (hypotension), which can require immediate clinical intervention to avoid organ damage or even death. Studies show that up to 48 percent of non-cardiac surgery patients experience a dangerous hypotensive event 1-4 days after surgery, which is associated with a 183 percent increase in post-op myocardial injury and death.
Medgadget: Please give us a quick summary of blood pressure monitoring and its importance.
Jeff Pompeo: Because blood pressure changes constantly, reliance on a typical "spot check" arm cuff blood pressure measurement provides only a single moment in time data point, leaving blind spots between intermittent readings where hemodynamic volatility is undetected. By contrast, continuous beat-by-beat blood pressure measurements eliminate blind spots and provide a real-time view of hypotensive decline so clinicians can make life-saving interventions immediately. Although frequent spot check blood pressure checks with typical arm cuffs are generally fine for healthy and stable patients, it's well-known that continuous BP monitoring for high-risk patients provides a far better picture of true hemodynamic health, and can help clinicians make better treatment decisions.
Medgadget: How is such monitoring conducted at present? How is this suboptimal?
Jeff Pompeo: The gold standard for continuous beat-by-beat blood pressure and hemodynamic monitoring is an invasive arterial catheter (a-line), which is inserted directly into a patient's artery and connected to a manually calibrated machine. But because of insertion difficulties, infection risks, and other challenges, a-lines are typically reserved for only the most critically ill patients under strict supervision in the ICU or OR. Therefore, the vast majority of patients are relegated to manual spot-check vital sign measurements taken every few hours, which of course means dynamic hemodynamic changes may go unnoticed and untreated for hours. Clinicians must therefore make decisions with incomplete and missing data. The COVID-19 pandemic has further stressed clinical staff and health system resources, making frequent manual vital sign checks even more challenging and increasing the risk that adverse events and errors may go unnoticed.

Medgadget: Please give us an overview of the VitalStream system and how it works.

Jeff Pompeo: VitalStream is a completely wireless, non-invasive, patient monitor that provides continuous beat-by-beat blood pressure, hemodynamic and vital signs monitoring, eliminating blind spots with uninterrupted real-time data without invasive a-lines. Using a disposable finger sensor and our Patented Decomposition Analysis (PDA™) technology, VitalStream measures continuous central aortic pressure and hemodynamics, but in a completely wireless platform to enable real-time and remote monitoring from anywhere. Continuous data and waveforms are streamed to our app or our remote secure cloud portal, or can be interfaced with EMRs and other platforms for automated reporting and streamlined workflow. VitalStream can be up and running on a patient in less than one minute and instantly alert clinicians to adverse hemodynamic events as they occur, even as patients move throughout the full continuum of care - even remotely after patient discharge. The VitalStream is FDA-cleared, and we have completed over a dozen clinical studies validating its accuracy. With VitalStream, patients are untethered from clunky cuffs, wires, and poles; clinicians enjoy automated workflow and continuous data for improved decision-making; and health systems can lower costs while improving care.
Medgadget: How does the VitalStream system measure continuous blood pressure, hemodynamics, and vital signs?
Jeff Pompeo: Our patented PDA™ Algorithms utilize a low-pressure finger sensor to analyze reflective waveforms in the aortic tree from each heartbeat. Our AI algorithms then derive changes in central aortic pressure to display waveforms and beat-by-beat values, as well as heart rate, respiration rate, and other parameters continuously. Using additional wireless sensors, VitalStream can also measure SpO2, ECG, body temperature, and ETCO2. All data is seamlessly displayed on our app, remote monitoring cloud portal, or integrated with EMRs and other monitors.
Medgadget: Congratulations on receiving FDA clearance for the system. Is the system already available to clinicians? If so, where is it currently being used?
Jeff Pompeo: Thank you. VitalStream is available for purchase now and more information is available on CaretakerMedical.net. We see a new paradigm where a VitalStream monitor stays with the patient on their journey across the full continuum of care, even going home after discharge, to create an uninterrupted digital record of personalized hemodynamic patient health - ultimately providing a path to predicting adverse events before they happen. Our current customers span a wide range of institutions and use-cases including critical care, trauma, perioperative settings, acute-care clinics, pharma clinical trials, infusion centers, sleep disorder labs, and remote patient monitoring. VitalStream checks every box of healthcare's quadruple aim by creating the opportunity for improved outcomes while being better for the patient, better for the clinician and better for the hospital.

Link: Caretaker Medical homepage...

Flashbacks: FDA Approves CareTaker® Wireless Remote Patient Monitor For Continuous Non-Invasive Blood Pressure ("cNIBP") and Heart Rate Monitoring using patented Finger Cuff Technology; Caretaker Beat-by-Beat Continuous Blood Pressure and Vital Signs Monitor Cleared in EU

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Wireless Blood Pressure and Hemodynamic Monitoring: Interview with Jeff Pompeo, CEO, Caretaker Medical

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Caretaker Medical, a company based in Virginia, developed the VitalStream wireless patient monitor, and the company recently announced that the device has received FDA clearance. The technology is intended to improve on traditional blood pressure cuffs that provide only a snap-shot of blood pressure data, while being an alternative, in many cases, over invasive arterial catheters that come with a variety of potential complications, including infections, and difficulties with insertion.

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- Change in workflows requiring input from multiple stakeholders
- Additional technical support if integrated in the inpatient and outpatient setting
- Increased patient awareness may lead to additional time needed for education on parameters and measurements
- Increased reliance on technology may reduce clinician skill in hands-on treatment