FDA Clears Caretaker Medical’s Wireless Monitor

Caretaker Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for four new continuous hemodynamic parameters, adding cardiac output, stroke volume, heart rate variability, and left ventricular ejection time to its VitalStream non-invasive patient monitoring platform. The company’s fifth FDA clearance expands the capabilities of its VitalStream wireless wearable, which is built for high-acuity, ICU-grade hemodynamic monitoring without limiting patient mobility or requiring invasive catheters and wires that tether patients to bedside equipment.

“Post-operative hypotension is a frequent occurrence that is unrecognized with intermittent spot checks-based monitoring in most hospital ward patients. Myocardial injury is strongly associated with hypotension in this period of recovery from surgery,” said Ashish Khanna, M.D., associate professor, vice chair for Research, Department of Anesthesiology, Section on Critical Care Medicine at Wake Forest University School of Medicine Center. “With FDA Cleared wireless wearable technology we can now continuously monitor a patient’s changing hemodynamic status through surgery and their entire hospital stay. The ability to noninvasively see beat-by-beat blood pressure and hemodynamic deterioration in real time allows us to make early interventions and potentially improve outcomes.”
 
The new advanced hemodynamic measurements are built on Caretaker’s proprietary Pulse Decomposition Analysis (PDA) waveform analysis technology which uses a simple and comfortable Finger Sensor to measure continuous cuffless blood pressure and  hemodynamics to eliminate “blind-spots” between manual spot-check measurements and enable high-acuity, uninterrupted monitoring across the continuum of care, including critical-care, sub-acute, emergency, medical-surgical floors, hospital-at-home and other environments. VitalStream provides actionable, beat-by-beat data to help clinicians identify patient deterioration earlier, intervene earlier, and optimize treatment decisions such as whether and when to administer fluids, drugs, or therapies.   
 
Continuous hemodynamic monitoring is performed to assess the impact that surgery, anesthesia or critical illness may have on a patient and to guard against adverse outcomes from hypotension or hypoperfusion. Post-operative hypotension is common and strongly associated with major vascular events. Complications of untreated hypotension with poor cardiac output can be severe and may lead to multi-organ failure and ultimately death.ⁱ Compared to existing invasive monitoring and expensive non-invasive alternatives, Caretaker Medical’s wireless and non-invasive advanced hemodynamic parameters are expected to reduce risk and cost, increase patient mobility, and enable clinicians & patients to benefit from comfortable, continuous, high-acuity monitoring.  
 
VitalStream is a non-invasive alternative to invasive A-Lines, arterial catheters, and intrusive hemodynamic methods, enabling ICU-grade patient monitoring across all points of care to provide clinicians with streaming patient data for early indications of patient deterioration, faster life-saving interventions, and better treatment decisions. VitalStream’s continuous beat-by-beat hemodynamics, waveforms, and vital sign data can be streamed remotely to the company’s mobile app or secure cloud portal or integrated into other monitoring systems and EMR’s with its FDA-cleared software interface SDK’s.
 
“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,” said Jeff Pompeo, Caretaker Medical’s CEO. “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.”
 
Perioperative studies show continuous hemodynamic monitoring could  save an estimated $970 per patientⁱⁱ and up to $1.2 million to $4.6 million for a hospital with 10,000 non-cardiac surgical patients per year.ⁱⁱⁱ 
 
The VitalStream wireless hemodynamic monitor is available immediately in the United States and is expected to be sold in Europe and Asia later this year.
 
Caretaker Medical, founded in 2014, is a Charlottesville, Va., based digital health company focused on developing wireless, high-acuity, continuous patient monitoring platforms that improve outcomes, increase clinician productivity, and maximize patient compliance and comfort. 

References
ⁱ Sharma S, Hashmi MF, Bhattacharya PT. Hypotension. [Updated 2022 Feb 16]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK499961/
ⁱⁱ Manecke GR, Asemota A, Michard F. Tackling the economic burden of postsurgical complications: would perioperative goal-directed fluid therapy help? Crit Care. 2014 Oct 11;18(5):566. doi: 10.1186/s13054-014-0566-1. PMID: 25304776; PMCID: PMC4207888.
ⁱⁱⁱ Keuffel EL, Rizzo J, Stevens M, Gunnarsson C, Maheshwari K. Hospital costs associated with intraoperative hypotension among non-cardiac surgical patients in the US: a simulation model. J Med Econ. 2019 Jul;22(7):645-651. doi: 10.1080/13696998.2019.1591147. Epub 2019 Mar 25. PMID: 30838899.