PhysIQ's patented personalized analytics to be used with newly expanded FDA labeling for COVID-19 treatment

The Food and Drug Administration (FDA) on 27 March 2020 approved the labeling of pinpointIQ ®, the continuous remote monitoring device for use in the COVID-19 pandemic, including the use of its proprietary Multivariate Shift Index (MCI).

PinpointIQ can be used during this pandemic to provide continuous remote physiological monitoring for homebound or quarantined patients with confirmed or suspected COVID-19 or those whose high-risk profile needs continuous remote monitoring, such as those with heart failure, COPD or hypertension. By actively gathering wearable sensor data and using advanced analytics, pinpointIQ will ease the burden on hospitals and other healthcare facilities and reduce the risk of exposure to SARS-CoV-2 for patients and healthcare professionals, and conserve resources for the very sick.

PhysIQ recently revealed the findings of a VA-sponsored clinical study published in Circulation – Heart Failure of 100 patients with congestive heart failure that was able to detect a week in advance subtle physiological changes predicting hospitalization. This study serves as a model for the future usefulness of our devices powered by artificial intelligence (AI) to detect specific cardiovascular changes that may occur in COVID-19 cases. PinpointIQ's feasibility is substantiated by the work that physIQ did with USAID during the Ebola epidemic. It supports the approach and the above use cases for how this platform / product will help mitigate the COVID-19 crisis.

Gary Conkright, CEO of PhysIQ said that COVID-19 is about to overtake our entire health-care system. We're going to have more patients than hospital beds and our only choice is to find ways to offer patients more treatment at home. We are supplying hospitals with customized physiological awareness for their homebound high-risk COVID-19 patients with clinical grade wearable sensors and our patented, FDA-cleared analytics. We assume that this would not only unlock hospital capability but also reduce clinician exposure to this highly virulent disease.

PhysIQ is a leading digital medicine business that uses continuous wearable biosensor data and sophisticated analytics to create unparalleled insight into the health. Our enterprise- cloud platform uses a deep portfolio of FDA- analytics to continuously capture and process data from any wearable biosensor. We have published one of the most comprehensive clinical studies in digital medicine to date, and are pioneers in the growth, validation and achievement of Artificial Intelligence- analytics regulatory approval. PhysIQ turns continuous physiological data into insight for healthcare systems, payers and pharmaceutical companies with applications in both healthcare and clinical trial support.

PhysIQ pursues several cases of clinical use, including successful patients with COVID-19, patients with chronic diseases such as heart failure or COPD, chemotherapy patients or other immune- treatment, and surveys health care providers at high risk of being contaminated. With the device, patients are mailed a package that provides all the necessary components for continuous remote monitoring, including FDA-cleaned clinical-grade wearable sensors and a data transmission phone with service plan. The system is delivered directly to the patient's house, so a clinician does not need direct physical interaction. Data streams continuously to the cloud where the patented FDA-cleaned analytics of physIQ detect subtle changes in physiology that could provide early warning of clinical deterioration related to COVID-19.