Sound Life Sciences scores FDA 510(k) for smart device respiratory monitoring

Sound Life Sciences has obtained FDA 510(k) certification for a prescribing app that uses a smartphone or smart speaker for respiratory monitoring at home or in a healthcare facility.

The tool works by allowing a smartphone or speaker to emit an inaudible ultrasonic pulse that is emitted from the patient’s chest and reflected back to the device. The app uses signal processing algorithms to capture any significant change in breathing, which then reports it to the user or clinician.

“It is important that our contactless technology uses devices such as smartphones or even smart speaker platforms that are familiar to most patients and provide care providers with health a remote key information set to make the most informed clinical decisions for their patients,” said Dr. Shyam Gollakota. , CEO and co-founder of Sound Life Sciences, said in a statement.

“As Acoustic Life Science leverages ubiquitous devices, our technology can scale quickly and unobtrusively to serve large and diverse populations in both urban communities and countryside, especially since it doesn’t require any additional hardware.”


University of Washington researchers studied proof-of-concept systems using smart speakers to measure heartbeat and identify respiratory changes may signal cardiac arrest.

Sound Life Sciences, a University of Washington scientist, said the trial to submit to the FDA included patients with COPD, asthma, congestive heart failure and anxiety. But the company wants to expand into other clinical areas.

“We are using this regulatory dynamic to accelerate the commercialization of our technology and begin to identify select partners to bring our software to market,” chief medical officer and co-founder, Dr. Jacob Sunshine said in a statement.

“This is just the beginning. With this basic justification, we have established a legal footing from which we can build additional use cases including chronic disease management.” respiratory characteristics such as asthma and COPD, monitor opioid safety, monitor neonates, detect neonatal respiratory tract infections, and identify when unexpected cardiac arrest occurs.

“There are so many clinical conditions that you can point to, and we focused on conditions where the detection of abnormal breathing could lead to evidence-based intervention and provide clear value.”


A higher level of care is being brought into the home as telehealth and remote monitoring technologies become more common.

In particular, Telehealth has expanded during the COVID-19 pandemic. ONE report from HHS showing percentage of Medicare visits performed via telehealth has increased 63-fold, increasing from about 840,000 in 2019 to 52.7 million in 2020.

There are also many companies that provide tools to Remote patient monitoring, including Current Health, signed an agreement to be acquired by retail giant Best Buy in October and Amazon, promoted Alexa voice assistant as a monitoring tool. Others in the space include Circadian rhythms, OnSky Health and VitalConnect.

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