PhysIQ announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their algorithm to continuously determine respiration rate in ambulatory patients. This clearance adds to their expanding portfolio of FDA-cleared cloud-based analytics, which also include QRS detection, heart rate, heart rate variability, atrial fibrillation detection, and their personalized physiology change detection analytic.
The latest clearance advances physIQ’s strategy to offer a deep portfolio of FDA-cleared analytics that can be applied to wearable sensor data. To enable this, physIQ’s platform collects raw telemetry from the device and uploads it to the cloud where FDA-cleared analytics use the raw biosignals to produce vital signs. With this approach physIQ is able to provide vital sign analytics that benefit from the superior computing power of the cloud and fuel the higher-level analytics that further characterize dimensions of human physiology. “In a real-world environment, respiration rate is a tough vital sign to accurately and consistently measure given high levels of motion artifact,” said Matt Pipke, co-founder and CTO of physIQ. “Given these challenges, it is ideal to be able to capitalize on the vast processing power and memory in the cloud to iron out the edge cases and outliers.”
Wearable sensors have enormous potential to transform how we understand and manage human health. However, these on-body sensors are collecting data in a noisy environment and, without sophisticated methods to manage signal noise, the resulting output is compromised. “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 the successful clearance of respiration as a core dimension of human cardiopulmonary physiology which will accelerate our development of further AI analytics.”
In addition to being a key clinical parameter, respiration rate is a key input to physIQ’s Multivariate Change Index (MCI), the analytic cleared in 2015 which detects subtle change in the tandem behavior of vital signs based on a personalized baseline of a patient. The MCI technique is designed to accommodate ambulatory variation from unconstrained activities of daily living. Change in the behavior of vital signs may provide evidence of evolving disease exacerbation as a precursor to hospitalization; and may provide evidence of the effect of a drug under trial.
It is substantially differentiating that, in a setting where many wearable devices are directed at non-regulated consumer-oriented applications, physIQ has committed to developing only medical grade devices that are vetted and formally cleared by FDA.