Summary:
U.K. medtech startup Acurable has gained FDA clearance for a novel wireless diagnostic device for remote detection of obstructive sleep apnea (OSA). Healthcare services often struggle to manage chronic conditions, given the expense of long term monitoring. But Rodriguez-Villegas explains that in the case of sleep apnea there is even a challenge for healthcare services to diagnose the condition — since traditional polysomnography tests are inconvenient and/or costly.
A formal launch into the U.S. market is slated to follow this summer. Its wearable is already being used by a number of hospitals in the U.K. (where it launched in 2021) and in the European Union, after obtaining local regulatory clearances in the region.
Article written by Natasha Lomas
26/05/2023
Source: Techcrunch
https://techcrunch.com/2023/05/24/acurable-acupebble-us-clearance/