PhysIQ, a company which applies AI analytics to biosensor data, has secured approval from the US Food and Drug Administration (FDA) for its Atrial Fibrillation (AFib) detection analytics engine.
Image: phsyIQ receives FDA approval for AFib analytics. Photo: Courtesy of Markus Spiske/Unsplash.
PhysIQ is dedicated to allowing proactive care delivery models via pinpointIQ, its highly scalable cloud-based platform for personalized physiology analytics.
The FDA 510(k) clearance extends physIQ’s portfolio of FDA approved analytics designed to generate clinical insight from wearable biosensors.
The newly cleared analytic is available within the ‘pinpointIQ’, the company’s AI analytics solution for patient care delivery along with its ‘accelerateIQ’ platform for clinical trials.
Atrial fibrillation is considered to a serious medical condition affecting 3-6 million Americans and is responsible for 750,000 hospitalizations and 130,000 deaths every year. It is also a significant contributor to complications of heart failure and data shows that between 20 and 35% of heart failure hospitalizations were associated with AFib.
physIQ’s AFib analytics engine will be available within its pinpointIQ monitoring solution, which will integrate clinical-grade wearable biosensors, mobile cloud computing and FDA-cleared analytics to provide clinicians with continuous insight for at-risk patients.
Presently, pinpointIQ is claimed to be in use by healthcare providers to better care for patients who were recently discharged from the hospital, recovering at a skilled nursing facility, or enrolled in a home health program.
Scripps Translational Science Institute Steven Steinhubl said: “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.
“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.”
physIQ also stated that besides supporting healthcare providers, the new AFib analytic will also be available for pharma and medical device companies that are integrating wearable biosensors into their clinical trials.
Life science companies can use this analytics to support safety endpoints within early and late stage trials.
physIQ chairman and CEO Gary Conkright said: “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.
“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.”