Fifth Eye in Ann Arbor Receives FDA Clearance for Medical Monitoring System

137
The AHI System from Fifth Eye keeps clinicians connected with their patients’ hemodynamic status and risks with easy-to-interpret visual communications. // Courtesy of Fifth Eye
The AHI System from Fifth Eye keeps clinicians connected with their patients’ hemodynamic status and risks with easy-to-interpret visual communications. // Courtesy of Fifth Eye

Fifth Eye in Ann Arbor, a provider of intuitive real-time clinical analytics, has announced the Food and Drug Administration (FDA) has provided clearance to market its second-generation clinical decision support software, the AHI system, to hospital in the U.S.

AHI stands for analytic for hemodynamic instability. Hemodynamic instability is a condition in which blood flow to vital organs is insufficient. Hemodynamic instability can occur suddenly. When left unnoticed or untreated, it is a known cause of significant morbidity and mortality in critically ill or injured patients. The system can detect hemodynamic instability in real-time from information embedded in an ECG signal alone.

“Hospitals and their staff are being stretched to their limits with over-crowded emergency rooms and ICUs,” says Jen Baird, CEO of Fifth Eye. “The AHI system provides physicians and nurses current, clinically validated insights regarding which patients may require additional vigilance to avoid an impending crisis.

“Conversely, AHI can bring the confidence of objective information to support the timely discharge or transfer of patients to lower acute settings, freeing up precious resources for additional patients.”

The release of the system brings a wealth of enhancements including a new analytic, the AHI Predictive Index (AHI-PI).  This can automatically and continuously predict the likelihood of future episodes of hemodynamic instability earlier than is possible with vital signs.

The AHI system provides at-a-glance awareness of patient risk by displaying a red, yellow, or green indicator on a multi-patient screen. Clinicians can access AHI through any browser-enabled device, including a mobile phone or tablet.

Since data is automatically collected and updated every two minutes, AHI reduces the surveillance burden on the nursing staff while providing access to new and valuable information to help them confidently prioritize their time.

In the FDA-reviewed clinical study, AHI-PI significantly differentiated critical care patients’ likelihood of developing hemodynamic instability. Patients with red high-risk indicators were 51 times more likely than those with green low-risk indicators to have an episode of hemodynamic instability in the next hour.

Additionally, AHI-PI high-risk indicators predicted 89 percent of first episodes of hemodynamic instability with a median lead-time of 48 minutes ahead of continuous arterial line blood pressure and heart rate vital signs.

The software is intended for use by healthcare professionals managing in-hospital patients 18 years or older who are receiving continuous physiological monitoring with ECG. AHI surveillance may be initiated on patients monitored with bedside, telemetry, or wearable patch ECG and standard electrodes.

For more information, click here.

Facebook Comments