Fifth Eye, a Michigan-based real-time clinical analytics company, announced today that the Food and Drug Administration has granted De Novo classification for its Analytic for Hemodynamic Instability (AHI) tool.
The technology links with hospitals' existing electrocardiograms to create a reading of patients' hemodynamic status every two minutes. Once AHI completes a reading, it uses machine learning to generate patient updates without vital sign assessment, manual data input in electronic health records or score calculation.
"The reason we tackled this problem is to provide the advantages of continuous real-time monitoring of hemodynamic status so that nurses don't actually have to put data into their systems or calculate anything to get the results," Jennifer Baird, the CEO of Fifth Eye, told MobiHealthNews. "The results of our system are very clear red and green outputs – red is a problem, green is not a problem."
In its FDA-reviewed clinical study of 222 adult critical care patients, AHI was able to identify hemodynamic instability with 96% sensitivity and could detect stable patients with 85% specificity compared with traditional vital signs-based monitoring methods.
"This identifies patients that are having a problem, but it also gives confidence to the caregivers that can help people get out of the hospital or transferred to a lower level of care," Baird said.
The AHI software is intended to be used by healthcare professionals managing patients in a hospital setting who are 18 years or older and who are being continuously monitored with an ECG.
WHY IT MATTERS
The goal of hemodynamic monitoring is to gauge how well blood is flowing through the body and is a common metric for patients in critical care units. When the blood flowing to organs is insufficient, the patient is hemodynamically unstable.
"Hemodynamic instability is the result of a variety of different problems," Baird said. "For example, somebody after surgery has an internal bleed that is hard to detect – this can detect that. Somebody that's turning septic or getting sepsis – this can detect that. Somebody that is struggling with COVID – it can detect that. So all of these different things that are points of deterioration or organ failure, this is a detector for that patient trend."
Traditional methods of hemodynamic monitoring range from invasive to noninvasive, intermittent to continuous, and require different methods and costs, according to Medicina Intensiva.
"So far, none of them meets all the necessary characteristics to be considered excellent: non-invasive, continuous, reliable, reproducible, comfortable for both the patient and the professional, accurate and with minimal side effects," the journal said.
Monitoring a patient's hemodynamic status is not an easy task for healthcare professionals today, according to Baird, but with the FDA De Novo classification, AHI can offer a noninvasive, real-time monitoring solution with clinical evidence.
"This is the first time that we can continuously monitor this particular problem and give that insight to the healthcare providers, the doctors and nurses, who need it," she said.
THE LARGER TREND
While AHI is the first software device to be granted De Novo classification by the FDA, the regulatory agency issued an emergency use authorization for a similar tool last October.
Called the COViage Hemodynamic Instability and Respiratory Decompensation Prediction System, the clinical decision support tool reviews demographic and vital-sign data stored in a patient's EHR to predict hemodynamic instability and respiratory decompensation.