FDA allows ultrasound-based breathing monitoring

Acoustic Life Science App for breath detection. (Photo Life Science Audio)

Sound Life Science Approved by the US Food and Drug Administration to market a breathing monitoring app, University of Washington announced Thursday.

This app relies on sonar technology for motion detection. A phone or speaker placed near the patient emits inaudible sound waves that bounce off the device’s microphone and the company’s software decodes the data.

“This is a really cool validation of technology. With the FDA, there is virtually no higher threshold to determine reliability and safety,” said chief medical officer Jacob Sunshine, UW associate professor of anesthesiology and pain medicine, in an interview with GeekWire.

Sound Life Sciences Chief Medical Officer Jacob Sunshine. (Photo Life Science Audio)

The app will allow people with conditions such as asthma or congestive heart failure, or patients recovering from certain surgeries, to monitor their respiratory rate. The company is now pushing its marketing team to partner with remote monitoring and other companies to offer the prescription-only app.

Future versions of this tool may provide additional functionality such as alerts for caregivers. “This is basically the first clearance from which we will build more interesting use cases,” Sunshine said. The company envisions applications such as monitoring infants and identifying cardiac arrest. Such improvements will likely require additional regulatory approval.

The app is “contactless,” while current options for monitoring breathing use some kind of hardware, such as electrodes, Sunshine said. For potential competitors, “there’s nothing quite like respiratory monitoring,” Sunshine said. People who measure breathing with the new app need to be fairly quiet, like with existing devices.

Sunshine founded the company nearly three years ago with Nicholas Mark, a pulmonologist and critical care physician at the Swedish Medical Center in Seattle, and Shyamnath Gollakota, a UW professor of computer science and engineering. The same UW technology also provides power a heart monitoring device growing company.

Gollakota, Sunshine and their colleagues also recently published a study on a wearable device to monitor breathing. That device is designed to detect opioid overdoses and inject an antidote, but uses separate technology and wasn’t developed by the startup.

The new app already has the FDA seal of clearance 510(k), indicating that it is “essentially equivalent” to another approved device. The FDA nod also opens the door for insurers to reimburse.

Sound Life Sciences has been supported by more than $2.5 million in grants from the National Institutes of Health and the Biomedical Advanced Research and Development Authority. It has six employees.

“We were a small team, but we were able to get FDA clearance and would normally need more people,” Sunshine said. “We were really focused.”

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