PhysIQ Respiration Rate Algorithm Cleared
FDA has cleared a PhysIQ 510(k) for use of the company’s algorithm to continuously determine respiration rate in ambulatory patients. The clearance adds to PhysIQ’s current portfolio of FDA-cleared cloud-based analytics, which also include heart rate, heart rate variability, atrial fibrillation detection, and a personalized physiology change detection analytic, the company says.
PhysIQ says it is also working to offer a 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,” it says. “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.”