ResApp granted European approval for wearable cough assessment device

Amid the growing concerns around coughing in public for the obvious reason, medtech company ResApp Health (ASX: RAP) has secured regulatory approval in Europe for their wearable device that analyses a person’s cough and the medical implications.

The device, which is yet to be named, can be easily clipped on to a person’s shirt where voice sensors can record coughs, analyse its audio patterns and store data to compare against future coughs. Cough frequency data can then be analysed by ResApp software to track respiratory disease progression and management.

“Achieving CE Mark is a major achievement, and we are confident that our wearable device will provide a number of commercial opportunities,” said ResApp CEO, Dr Tony Keating.

“Discussions with potential partners, including global pharmaceutical companies, to introduce the wearable device into clinical trial settings have already commenced.

“The availability of the device provides a strong value proposition to potential partners and allows ResApp another opportunity to commercialise new products aimed at assessing and predicting respiratory disease progression.”

By securing CE Mark certification as a Class I medical device accessory, ResApp can progress to commercial manufacturing and sale of the device in Europe. Production will be managed by OSI Electronics which has manufacturing facilities in the United Kingdom and South East Asia while ResApp pursues further software development that will be drawn from data collected by users of the wearable device.

Initially, it will be introduced in clinical trial settings across a broad range of diseases where coughing is symptomatic before a more detailed commercial strategy is rolled out for end users suffering from chronic obstructive pulmonary disease (COPD) or asthma.

With data-backed precision and accuracy, ResApp’s device can identify over 93% of cough events and unlike existing solutions, it does not require manual review of audio by an analyst, thus enabling rapid analysis of coughs.

At present, neither the device or software provide diagnostics directly linked to COVID-19.