PhysIQ recently received FDA 510(K) clearance for its atrial fibrillation detection analytics system.
The clearance expands the company’s cleared analytics that are designed to create clinical insight from wearable biosensors, commercializing AI-based physiology analytics. The recently cleared analytic system is available through the company’s pinpointIQ for patient care delivery and 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,” Steven Steinhubl, associate professor of genomic medicine in the department of molecular medicine at Scripps research, said in a press release. “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 characterized by a quivering or irregular heartbeat. Approximately 2.7 million Americans are currently living with the condition, according to the American Heart Association. Atrial fibrillation can lead to blood clots, stroke, heart failure and other heart-related complications. It is responsible for 20-35% of heart failure hospital admissions.
PhysIQ’s analytics system is used in its pinpointIQ monitoring system. It combines clinical-grade wearable biosensors, mobile cloud computing and FDA-cleared analytics to provide clinicians with continuous data from patients who are at-risk of AFib. PinpointIQ is currently in-use by payers and providers to help care for patients who have been recently discharged from the hospital, recovering at a skilled nursing facility or patients who are 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,” Gary Conkright, chairman and CEO of PhysIQ, said. “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.”
The newly cleared AFib detection analytics system is available to pharma and medical device companies that are working on bringing wearable biosensors to clinical trial.