News

Caretaker Medical Receives FDA Clearance for 4 new Non-Invasive Hemodynamic Parameters

Caretaker Medical, a digital health leader in continuous “beat by beat” wireless patient monitoring technologies, announced that it has received 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. This is the company’s 5th FDA Clearance expanding the capabilities of its industry leading 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.

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 hypo-perfusion. 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 their FDA-cleared software interface SDK’s.

Perioperative studies show continuous hemodynamic monitoring could save an estimated $970 per patient[i] and up to $1.2 – $4.6 million for a hospital with 10,000 non-cardiac surgical patients per year[ii]. Caretaker’s VitalStream™ provides key benefits to hospitals, clinicians and patients by providing thousands of “beat-by-by-beat” insights per minute that can lead to early interventions and reduced complications; automating data collection and reporting for improved nurse productivity and staff optimization; and enabling faster patient transition to lower cost beds without compromising monitoring safety.

The VitalStream™ wireless hemodynamic monitor is available immediately in the USA directly from the company and its distribution partners. Caretaker Medical expects to make VitalStream™ available in Europe and Asia later this year.

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