No-Contact Breathing Monitor Now Has FDA Clearance

Software that uses a smartphone or smart speaker to monitor breathing now has FDA 510 (k) clearance. The clinically validated app was developed by the University of Washington spinout company, Sound Life Sciences. It uses sonar to detect changes in breathing. Before granting clearance, the FDA reviewed data from trials involving patients with asthma, congestive heart failure, COPD, and anxiety.

Researchers at UW created the app to provide remote patient monitoring that helps manage chronic disease and prevent life-threatening emergencies. The software uses the phone or speaker to send out pulses of inaudible ultrasonic waves, which reflect off the patient’s chest back to the built-in microphone. The app measures the frequency of the reflected sound waves. Algorithms then analyze frequency patterns to identify abnormal changes in breathing.

The software has performed well in several clinical trials. In one study published in the journal nature: npj digital medicine, the software detected agonal breathing — which is associated with cardiac arrest — with 97% accuracy from up to 20 feet away. Another study, published in Science Translational Medicine, showed that the software’s algorithm identified 19 out of 20 simulated opioid overdose events.

Having received FDA clearance, Sound Life Sciences intends to work with partners to market the software for a broad range of applications. In addition to the conditions mentioned above, the app offers contactless monitoring for infants, opioid safety, cardiac arrest, and respiratory infections. The sonar app uses devices that most patients already own, is easy to calibrate, and can communicate data to providers instantly, which makes the solution both affordable and scalable.

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