Sound Life Sciences Receives FDA 510(k) Clearance for Industry's First Contactless Sonar-based Respiratory Monitor for Smart Devices

Sound Life Sciences, a pioneer in contactless respiratory monitoring with its proprietary sonar software for consumer smart devices, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The privately-held telehealth startup's smartphone or smartspeaker app produces inaudible ultrasonic sonar pulses to detect reflections caused by nearby patient respiration.

The prescription-only application can be used in home or clinical settings to measure breathing. Testing as part of the FDA submission involved patients with conditions such as chronic respiratory pulmonary disease (COPD), asthma, congestive heart failure and anxiety.

"We're using this regulatory momentum to accelerate commercialization of our technology and begin to identify select partners to bring our software to market," said Jacob Sunshine, MD, Chief Medical Officer and Co-Founder of Sound Life Sciences. "This is just the beginning. With this foundational clearance we have established a regulatory foothold, from which we can build out additional use cases including for respiratory chronic disease management such as asthma and COPD, opioid safety monitoring, infant monitoring, incipient respiratory infection detection and identifying when an unwitnessed cardiac arrest occurs. There are many clinical conditions you can point this at and we are laser focused on conditions where detecting aberrant breathing can lead to an evidence-based intervention and clearly provide value."

"It's critical that our contactless technology utilizes devices like a smartphone or even smartspeaker platforms which are familiar to most patients, and offers health care providers in a telehealth setting critical information to make the most informed clinical decisions for their patients," said Shyam Gollakota, PhD, CEO and Co-Founder of Sound Life Sciences. "Because Sound Life Sciences leverages ubiquitous devices, our technology can rapidly and unobtrusively scale to serve large and diverse populations in both urban and rural communities, especially as it does not require any additional hardware."

Sound Life Sciences has received more than $2.5MM in funding from the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA). Research from the company's founders has been published in more than a dozen peer-reviewed journals and featured in top-tier media outlets including New York Times, Washington Post, STAT, ABC News and Scientific American.

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About Sound Life Sciences: The University of Washington spinout, founded in 2018, is a computational health company that builds clinically validated software for mobile phones and smart speakers to advance human health.