FDA clears PeraHealth's lifesaving clinical surveillance tech

Groundbreaking technology from PeraHealth that monitors patient health and flags up anomalies has been given the green light by the Food and Drug Administration (FDA).

PeraTrend is the first solution of its kind to be granted 510(k) clearance by the FDA, which means the product – at this stage of premarket submission – was deemed at least as safe and effective as a legally marketed device.

The predictive real-time clinical surveillance technology improves patient outcomes by combining a patient’s Electronic Health Record (EHR) with measures that quantify and visualise patient deterioration, risk and improvement. It is already being used in hospitals and healthcare systems across the US.

PeraTrend uses the Rothman Index (RI) to check on a range of physiological measures – including lab results, vital signs and nursing assessments – to produce a continuous measure of a patient’s condition across diseases, conditions and levels of care, with trends indicated before a situation becomes critical.

The RI provides a statistically validated patient acuity score across all diseases and conditions.

Michael Rothman, PeraHealth’s chief science officer and co-founder, said, “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."

“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-centred value-based care, including mortality reduction and earlier identification of sepsis.”

PeraHealth’s founders, Michael and Steven Rothman, were inspired to create the RI after the death of their mother, Florence. While she received good care after a low-risk heart procedure, the subtle changes in her condition were not picked up and she died despite there being a wealth of data available.

The brothers approached the hospital in which their mother had been treated and found a way to bring together the EHR and other health measures to help medics spot, and act on, any deterioration in a patient’s condition.