Press ReleasePeraHealth receives U.S. FDA 510(k) clearance for industry-leading clinical surveillance technology
Rothman Index-powered technology trusted by leading healthcare organizations nationwide
CHARLOTTE, N.C. (May 3, 2018) – PeraHealth today announced that its predictive, real-time clinical surveillance technology, PeraTrend, is now the first solution of its kind to receive 510(k) clearance from the U.S. Food and Drug Administration (FDA). PeraTrend is trusted by leading healthcare systems across the United States, including Yale New Haven Health System, Houston Methodist Health and Mission Health, where PeraHealth CEO Stephanie Alexander announced this pivotal achievement.
“Improving quality of patient care is our focus, which is why securing clearance from the FDA, which oversees and protects public health, is a major milestone for PeraHealth and for the clinical surveillance market,” said Alexander. “Although FDA guidelines on clinical surveillance solutions are evolving, it was important for us to lead the way and complete the rigorous process for clearance, which provides an additional, trusted seal of approval to our work.”
PeraHealth solutions are powered by the Rothman Index (RI), a comprehensive measure of the patient condition for healthcare providers, leveraging data within a hospital’s existing electronic health record (EHR) to quantify and visualize patient deterioration, risk and improvement in real time. While other solutions depend on vital signs alone, the peer-reviewed RI model uses a range of physiological measures – including labs, vital signs and nursing assessments – to produce a continuous measure of patient condition across diseases, conditions and levels of care, trended over time.
“The FDA’s extensive validation steps provide further evidence of the Rothman Index as the clinical gold standard in measuring patient condition across the acuity spectrum,” said Michael Rothman, Ph.D., PeraHealth’s Chief Science Officer and co-founder. “The model we created 10 years ago benefits thousands of patients every day and is backed by more than 40 peer-reviewed articles. PeraHealth will continue to research, innovate, and share strategies for enhancing patient-centered value-based care, including mortality reduction and earlier identification of sepsis.” PeraHealth shared the FDA decision today at the PeraHealth RI Roundtable. This annual conference brings together dedicated physicians, nurses, informaticists and other healthcare leaders, all working to reduce care variation using the research-based Rothman Index.
Customers are presenting successes this week about various clinical surveillance topics including proactive rounding, creating protocols, increasing ICU optimization, reducing readmissions, initiating palliative care, and communicating with patients and families.
PeraHealth is transforming healthcare through the intelligent use of data. PeraHealth solutions, powered by the Rothman Index, provide a visual representation of the patient’s condition and progress in real time. Leading hospitals and health systems utilize PeraHealth predictive analytics to improve quality and reduce cost. Clinical results include reducing all-cause mortality rates, length of stay, and readmissions. For more information, visit