FDA clearance differentiates Rothman Index product development and is a major milestone for the clinical surveillance market
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PeraHealth announced that its predictive clinical surveillance applications for command centers and mobile devices are now the first solutions of their kind to receive 510(k) clearance from the US Food and Drug Administration (FDA). Leading healthcare systems including Yale New Haven Health System, Houston Methodist, and Mission Health trust the Rothman Index to improve patient care.
The Rothman Index is the only algorithm that derives one simple score from the vast amount of data in the electronic medical record to create a picture of any patient’s condition over time – any age, any disease, any unit. While other solutions depend on vital signs alone, the peer-reviewed Rothman Index uses a range of physiological measures – including labs, vital signs and nursing assessments – to produce a continuous measure of patient condition, trended over time.
Using Rothman Index technology, PeraWatch v4 provides global surveillance capabilities, supporting hospital command centers with system-wide, remote surveillance for hundreds of patients at a glance. PeraMobile v4 provides mobile device access for timely response to patient alerts, organized by warning level and customized watch lists. With the new FDA clearance, these applications join PeraTrend, which received FDA 510(k) clearance in May 2018.
“FDA clearance differentiates Rothman Index product development and is a major milestone for the clinical surveillance market,” says Greg White, CEO, PeraHealth. “We continue to lead the way by seeking the rigorous clearance process, including extensive Human Factors testing with experienced clinicians to eliminate potential use errors.”
Source: Company Press Release