Sound Life Sciences received FDA 510 (k) clearance for its prescription app that uses a smartphone or smart speaker to monitor breathing in the home or clinical setting.
The tool works by allowing a smartphone or speaker to send out inaudible ultrasound pulses that ricochet off a patient’s chest and reflect back to the device. The app uses signal processing algorithms to record significant changes in breathing, which are then reported to the user or doctor.
“It is critical that our contactless technology leverages devices such as smartphones or even smart speaker platforms that most patients are familiar with and provides healthcare providers in a telemedicine environment with critical information to help their patients make the most informed clinical decisions,” Shyam Gollakota, PhD, CEO and Co-Founder of Sound Life Sciences, said in a statement.
“With Sound Life Sciences leveraging ubiquitous devices, our technology can be quickly and unobtrusively scaled to serve a large and diverse population in both urban and rural communities, especially since no additional hardware is required.”
WHY IT IS IMPORTANT
Researchers at the University of Washington have studied proof-of-concept systems using smart speakers to make Measure heart rhythm and identify changes in breathing that could indicate cardiac arrest.
Sound Life Sciences, a spin-out from the University of Washington, said tests for its submission 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 leveraging this regulatory dynamic to accelerate the commercialization of our technology and begin looking for selected partners to bring our software to market,” said Dr. Jacob Sunshine, chief medical officer and co-founder, in a statement.
“That’s just the beginning. With this fundamental release, we have created a regulatory foundation from which we can build additional use cases, including managing chronic respiratory diseases such as asthma and COPD, monitoring opioid safety, monitoring infants, detecting incipient respiratory infections, and detecting unnoticed cardiac arrest occurs.
“There are many clinical conditions for you to point out, and we are laser focusing on conditions where detecting abnormal breathing can lead to evidence-based intervention and clearly add value.”
THE BIGGER TREND
Higher-level care is moving into the home as remote monitoring and telehealth technology become increasingly important.
Telemedicine in particular has expanded during the COVID-19 pandemic. A HHS report found that the proportion of Medicare visits made via telemedicine increased 63-fold, from approximately 840,000 visits in 2019 to 52.7 million in 2020.
There are also a variety of companies that have tools for Remotely monitor patients, including Current Health, which signed an agreement to acquire it by retail giant Best Buy in October, and Amazon, which is promoting its voice assistant Alexa as a monitoring tool. Others in this area are Biobeat, OnSky Health, and VitalConnect.