Hear, hear: Sound Life Sciences wins FDA OK for app that uses sonar to measure breathing

Bats
By emitting inaudible sonar pulses, Sound Life Sciences’ app can turn any smartphone or smart speaker into a clinical-quality respiratory monitor without requiring any additional equipment. (Marcel Langthim/Pixabay)

Smartphones grow smarter by the minute. For their latest feat, they’re taking cues not from humans, but from bats, dolphins, whales and other echolocation-reliant animals.

A newly FDA-cleared app from Sound Life Sciences uses sonar technology to transform an individual’s existing smartphone or smart speaker into a clinical-grade respiratory monitor—completely eliminating the need for any specialized equipment to track breathing rate.

The 510(k) clearance indicates the app for prescription-only use in both home and clinical settings. In studies submitted to the agency for authorization, the software was used to monitor patients with chronic obstructive pulmonary disease (COPD), asthma, congestive heart failure, anxiety and more.

“Our contactless technology... offers healthcare providers in a telehealth setting critical information to make the most informed clinical decisions for their patients,” said Shyam Gollakota, Ph.D., Sound’s CEO and co-founder. “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.”

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Once the app has been downloaded and calibrated on a phone or speaker, it puts out inaudible ultrasonic sonar pulses that bounce off a patient’s chest. When those reflections return to the device, its microphone captures the findings, which are then analyzed by Sound’s signal processing algorithms.

If the software detects clinically meaningful shifts in respiratory frequency, “emergency mode” is triggered, prompting the patient’s caregivers and healthcare providers to intervene and seek help as necessary.

The technology is backed by more than $2.5 million in funding from the National Institutes of Health and the federal Biomedical Advanced Research and Development Authority as well as clinical research published by the company’s scientists while conducting research at the University of Washington.

“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,” said Jacob Sunshine, M.D., chief medical officer and Gollakota’s co-founder at Sound.

“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,” Sunshine continued.

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Both smartphones and smart speakers are rapidly becoming vital medical devices. In the U.K., for example, since 2019, Amazon Echo owners have been able to ask Alexa for advice about common illnesses, from migraines to the flu.

In that same time period, the FDA has dished out a handful of approvals and clearances for smartphone apps that not only monitor health conditions, but have been proven in clinical trials to treat them, as well. Some of the latest digital therapeutics to be greenlighted by the agency include programs claiming to treat irritable bowel syndrome, ADHD, substance use disorder and more.