FDA 510(k) cleared Beat Detection analytic allows physIQ to power its higher-level AI analytics with validated vital sign inputs.
This clearance would not be possible if not for physIQ’s unprecedented 1.5 million+ hours of continuous biosensor data. Only with physIQ’s unique capabilities can you manage the wearable signal to noise ratios for an accurate output.
CHICAGO, IL– August 20, 2020 –PhysIQ, a leader in applying artificial intelligence to wearable sensor data, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their continuous remote monitoring algorithm designed to improve physiologic monitoring accuracy by levering the power of deep neural network computational approaches. This clearance adds to their expanding portfolio of FDA-cleared cloud-based analytics, which also include heart rate, heart rate variability, atrial fibrillation detection, respiration rate, and its personalized physiology change detection analytic.
PhysIQ’s latest Heart Rhythm and Respiration Module (HRRM) takes advantage of the massive data trove of biosensor data collected from a variety of clinical studies and heterogeneous populations and healthcare applications. “It is important to note that the data comprises well over 1,000 subjects diagnosed with diseases and conditions such as heart failure, COPD, Alzheimer’s, sepsis, as well as healthy subjects,” said Stephan Wegerich, physIQ’s Chief Science Officer. “Many of the algorithms that make up HRRM are based on state-of-the-art deep neural network techniques that generally require large and diverse datasets to train properly. It would not have been possible to achieve the level of accuracy and generalizability without the availability of data trove representing real world physiology.”
Wearable sensors have transformed how we understand and manage human health. However, wearable biosensors are typically collecting data in a very noisy environment. Without sophisticated methods to manage signal-to-noise, it nearly impossible to calculate vital signs accurately, except during periods when the patient is not moving.
“Accurate and precise vital signs are an essential component of a clinical grade remote intelligence solution but, ultimately, these vital signs are an input into the higher-level AI-based analytics for which physIQ is known” said Gary Conkright, chairman and CEO of physIQ. “We are encouraged by this successful clearance that will continue to accelerate our development of further AI analytics.”
Many wearable devices today are directed at non-regulated consumer-oriented general-wellness applications. It is substantially differentiating that physIQ has committed to developing only medical grade devices that are vetted and formally cleared by FDA.
PhysIQ is a leading digital medicine company dedicated to generating unprecedented health insight using continuous wearable biosensor data and advanced analytics. Its enterprise-ready cloud platform continuously collects and processes data from any wearable biosensor using a deep portfolio of FDA-cleared analytics. The company has published one of the mostrigorous clinical studiesto date in digital medicine and are pioneers in developing, validating, and achieving regulatory approval of Artificial Intelligence-based analytics. With applications in both healthcare and clinical trial support, physIQ is transforming continuous physiological data into insight for health systems, payers, and pharmaceutical companies.