www.fdanews.com/articles/205725-sound-life-sciences-gets-fdas-510k-clearance-for-sonar-based-respiratory-monitor
Sound Life Sciences Gets FDA’s 510(k) Clearance for Sonar-based Respiratory Monitor
December 10, 2021
Sound Life Sciences has received the FDA’s 510(k) clearance for its sonar-based app for monitoring patients’ respiration.
The prescription-only application, which can be used with a smartphone or smart speaker in home or clinical settings, produces inaudible ultrasonic sonar pulses that allow it to detect nearby patient respiration.
Testing to support the FDA submission included patients with conditions, such as chronic respiratory pulmonary disease, asthma, congestive heart failure and anxiety, the company said.