physIQ announces FDA-sanctioned labeling to address the COVID-19 public health emergency with its proprietary Multivariate Change Index (MCI)
Deployed within thepinpointIQ® continuous remote monitoring solution, physIQ’s MCI will be used to proactively monitor homebound patients with or vulnerable to COVID-19
The sophisticated, machine learning-based algorithm uses multiple continuous vital signs from wearable sensors to detect subtle changes in physiology that may offer early detection of COVID-19-related clinical deterioration
CHICAGO, IL– March 26, 2020 – The Food and Drug Administration (FDA) has sanctioned labeling forpinpointIQ®, physIQ’s continuous remote monitoring system for use in the COVID-19 pandemic, including application of its proprietary Multivariate Change IndexTM(MCI). During this pandemic,pinpointIQmay be used to provide continuous physiologic remote monitoring to homebound or quarantined patients with confirmed or suspected COVID-19 or those whose high-risk profile that requires continuous remote monitoring, for example, those with heart failure, COPD, or hypertension. By passively collecting wearable sensor data and applying advanced analytics,pinpointIQmay ease burden on hospitals and other healthcare facilities and reduce the risk of exposure for patients and healthcare providers to SARS-CoV-2 and conserve resources for the very sickest.
Recently, physIQ announced the results of aVA-sponsored clinical studypublished inCirculation – Heart Failureof 100 patients with congestive heart failure that was able to detect subtle physiologic changes predictive of hospitalization one week in advance. This study serves as a model for the potential utility of our artificial intelligence (AI)-powered devices to detect similar cardiovascular changes that may emerge in COVID-19 cases. The viability of pinpointIQ is substantiated by the work physIQ has done with USAIDduring the Ebola epidemic. This supports the solution and the previously stated use cases for how this platform/product can aid in the COVID-19 crisis mitigation.
“Our entire healthcare infrastructure is about to become completely overwhelmed by COVID-19,” said Gary Conkright, CEO of physIQ. “We will have more patients than hospital beds and our only option is to find ways to better care for patients at home. With clinical grade wearable sensors and our proprietary, FDA-cleared analytics, we are providing hospitals with personalized physiologic visibility into their homebound high-risk COVID-19 patients. We believe this will not only free up hospital capacity, but also reduce clinician exposure to this highly virulent disease.”
physIQ is pursuing multiple clinical use cases including COVID-19 positive patients, patients with chronic diseases such as heart failure or COPD, patients on chemotherapy or other immune-suppressive therapy, and to surveille healthcare providers who are at elevated risk of getting infected themselves. With the system, patients are mailed a kit that provides all components required for continuous remote monitoring including FDA-cleared clinical-grade wearable sensors and a phone for data transmission with data plan. The system is deployed directly to patient’s home, requiring no direct physical contact from a clinician. Data continuously streams to the cloud where physIQ’s proprietary FDA-cleared analytics detect subtle changes in physiology that may offer early warning of clinical deterioration related to COVID-19.
physIQ is a leading digital medicine company dedicated to generating unprecedented health insight using continuous wearable biosensor data and advanced analytics. Our enterprise-ready cloud platform continuously collects and processes data from any wearable biosensor using a deep portfolio of FDA-cleared analytics. We have published one of the mostrigorous clinical studiesto date in digital medicine and are pioneers in developing, validating, and achieving regulatory approval of Artificial Intelligence-based analytics. With applications in both healthcare and clinical trial support, physIQ is transforming continuous physiological data into insight for health systems, payers, and pharmaceutical companies. For more information, please visitwww.physIQ.com. Follow us onTwitterandLinkedIn.