The Loop System, a continuous remote monitor developed by Palo Alto-based startup Spry Health, received 510(k) clearance from the FDA last Friday, according to an update to the agency’s databasethat was confirmed by the company.
Designed for management of COPD and other chronic conditions, the wristband wearable collects and monitors a user’s pulse-oximetry, respiration, heart rate and blood pressure (although the device’s webpage notes this last feature is designed for researchers). These data are automatically analyzed to identify clinically relevant signs of deterioration, with any changes highlighted for providers on an accompanying dashboard.
The device works out of the box and requires no inputs from the wearer, although they do have to option to view updates about their condition on the display and may receive notifications if any changes are detected.