FDA Grants 510(k) Clearance to physIQ’s AFib Detection Analytics Engine

PhysIQ, a leader in applying AI analytics to biosensor data, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its atrial fibrillation (AFib) detection analytics engine. The clearance extends physIQ’s portfolio of FDA 510(k)-cleared analytics designed to generate clinical insight from wearable biosensors and further establishes physIQ as a leader in developing, validating, and commercializing AI-based physiology analytics. The newly cleared analytic is available within the pinpointIQ solution for patient care delivery as well as the company’s accelerateIQ platform for clinical trials.
 
“Once a patient leaves the hospital, a clinician’s ability to track his/her progress traditionally has been limited, which is why we historically have seen high readmission rates,” said Dr. Steven Steinhubl of the Scripps Translational Science Institute. “This FDA clearance is another example of how physIQ’s AI expertise is ushering in an era where advanced personalized physiology analytics applied to continuous biosensor data can give clinicians the insight they need to drive down rehospitalizations and accelerate our pace towards personalized precision medicine.”
 
Atrial fibrillation is a serious medical condition that affects 3 million to 6 million Americans and is responsible for 750,000 hospitalizations and 130,000 deaths each year. However, beyond its clinical significance as a stand-alone condition, AFib is a significant contributor to complications of heart failure, where data indicates that 20 percent to 35 percent of heart failure hospital admissions are associated with AFib at presentation.¹ The recently cleared AFib analytic will be available within physIQ’s pinpointIQ monitoring solution, which combines clinical-grade wearable biosensors, mobile cloud computing, and FDA-cleared analytics to provide clinicians with continuous insight for at-risk patients. PinpointIQ is currently being used by payers and providers to better care for patients recently discharged from the hospital, recovering at a skilled nursing facility, or enrolled in a home health program.
 
“Since day one our mission has been to enable a world where real time patient data continuously streams to the cloud and artificial intelligence performs the hard work of detecting when health problems are arising among monitored patients,” said Gary Conkright, chairman and CEO of physIQ. “With this approach, clinicians can identify who within their monitored population may require additional care to avoid poor health outcomes. This clearance of our AFib detection algorithm, when paired with our groundbreaking and previously cleared personalized physiology analytics, is a huge step towards realizing that goal.”
 
In addition to supporting providers at health systems and payers, the FDA-cleared AFib analytic is also available to pharma and medical device companies that are integrating wearable biosensors into their clinical trials. In this capacity, life science companies can utilize the analytics to support safety endpoints within early and late stage trials.
 
PhysIQ is a company dedicated to enabling proactive care delivery models through pinpointIQ, a highly scalable cloud-based platform for personalized physiology analytics. The company’s FDA 510k-cleared data analytics platform is designed to process multiple vital signs from wearable sensors to create a personalized dynamic baseline for each individual. By mapping vital sign relationships this way, physIQ’s analytics detect subtle deviations that may be a precursor to disease exacerbation or change in health. With applications in both healthcare and clinical trial support, physIQ is transforming continuous physiological data into insight for providers, health systems, payers, and pharmaceutical and medical device companies.

Reference
1. https://www.ahajournals.org/doi/full/10.1161/CIRCHEARTFAILURE.108.830349