Ann Arbor company gets FDA OK for patient safety software

ANN ARBOR—Fifth Eye, a medical software startup developing real-time clinical analytics,  announced that the U.S. Food and Drug Administration has provided clearance to market its second generation clinical decision support software, the AHI System, to hospitals in the United States.

AHI, pronounced AH-hee, stands for Analytic for Hemodynamic Instability. Hemodynamic instability is a condition in which blood flow to vital organs suddenly becomes insufficient.  When left unnoticed or untreated, it can cause death in critically ill or injured patients. AHI, Fifth Eye’s first analytic, can detect hemodynamic instability in real-time from information embedded in an electrocardiogram signal alone.

The release of the AHI System brings a wealth of enhancements including a new analytic, the AHI Predictive Index (AHI-PI). AHI-PI can automatically and continuously predict the likelihood of future episodes of hemodynamic instability earlier than is possible with vital signs. Early awareness of emerging problems provides clinicians with precious time that may facilitate early intervention to mitigate or avoid a crisis.

The AHI System provides at-a-glance awareness of patient risk with traffic-light simplicity 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. And 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.

“Hospitals and their staff are being stretched to their limits with over-crowded emergency rooms and ICUs,” said Jen Baird, Fifth Eye CEO. “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.”

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 51x 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% 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.

AHI System 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.

More at www.fiftheye.com.

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