FDA gives clearance to sonar-based app that monitors breathing

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Sound Life Sciences App for breathing detection. (sound life science photo)

sound life science Has approval from the US Food and Drug Administration to market its app for breathing monitoring, a University of Washington spinout announced Thursday,

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The app is based on sonar technology for movement detection. A phone or speaker placed near a patient emits inaudible sound waves that bounce back to the device’s microphone, and the company’s software decodes the data.

“It’s a really great validation of the technology. With the FDA, there’s almost no high bar to articulate about reliability and safety,” said the chief medical officer. jacob sunshinea UW associate professor of anesthesiology and pain medicine, in an interview with GeekWire.

Jacob Sunshine, chief medical officer of Sound Life Sciences. (sound life science photo)
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The app will enable people with conditions like asthma or congestive heart failure or patients recovering from certain surgeries to track their respiratory rate. The company is now ramping up its marketing team for remote monitoring and partnering with other companies to provide a prescription-only app.

Future versions of the tool may provide additional functionality such as alerting the caregiver. “This is basically the first approval from which we will be building more exciting use cases,” Sunshine said. The company envisions uses such as baby monitoring and detecting cardiac arrest. Such reforms would require additional regulatory approval.

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The app is “contactless,” while existing options for monitoring breathing use some form of hardware, such as electrodes, Sunshine said. For potential competitors, “there isn’t much in the way of respiratory monitoring,” Sunshine said. People measuring respiration with the new app need to be fairly stable like existing devices.

Sunshine founded the company about three years ago Nicholas Mark, a pulmonary and critical care physician at Swedish Medical Center in Seattle, and Shyamnath Golkota, UW Professor of Computer Science and Engineering. Similar UW technology also powers a heart monitoring device the company is developing.

Golcotta, Sunshine and their colleagues also recently published a study on wearable devices to monitor breathing. That device is designed to detect opioid overdoses and inject an antidote, but uses different technology and is not being developed by the startup.

The new app received an FDA seal through 510(k) approval, indicating it is “substantially equivalent” to any other, approved device. FDA approval also opens the door to reimbursement by insurers.

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

“We’re a small team, but we were able to get FDA approval and it usually takes a lot more people,” Sunshine said. “We’re really focused.”

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