PhysIQ, which is developing machine learning-based solutions for remote patient monitoring, has received FDA 510(k) clearance for its Personalized Physiology Analytics (PPA) Engine Software. Categorized as a Class II device for patient monitoring, said software is the first FDA-cleared device to receive the new product code PLB: Automated calculation of a summary index based on several individual measured vital sign inputs.
“This first clearance from the FDA for the algorithm that forms the basis for this technology is a critical step in the roadmap to demonstrating that the PhysIQ product will be a pivotal tool for monitoring patients with a variety of chronic diseases,” according to Dr. Susan Alpert, regulatory advisor to PhysIQ and former Director of the Office of Device Evaluation (ODE) at FDA’s Center for Devices and Radiological Health (CDRH). PhysIQ is planning to evaluate the PPA platform in several clinical studies of patients with heart failure, chronic obstructive pulmonary disease (COPD), and infectious diseases.
The company’s PPA software can accept and integrate data input from a range of commercial monitors providing continuous vital signs such as heart rate, respiration rate, and body motion. It is able to cope with variations with normal activities of daily living, and different patient vital sign patterns that can vary with age, gender, weight, and health condition. The PhysIQ platform constructs a personalized baseline norm for each person monitored, rather than simple trending or comparison to population-based statistics. In this way, the platform is intended to accommodate vital sign dynamics caused by normal human activities, while detecting changes above and beyond baseline variation and interpersonal differences.
Company founders previously developed and commercialized the technology for monitoring complex, mission-critical commercial jet engines and other machine applications, at a prior company that was ultimately acquired by GE Intelligent Platforms.