Spry Health announces that the U.S. Food and Drug Administration (FDA) cleared to market the company’s Loop System. Loop is a clinical-grade wearable that measures pulse oximetry, respiration rate and heart rate. With this FDA clearance, clinicians will now have a tool to remotely monitor their patients with chronic diseases, such as chronic obstructive pulmonary disease (COPD), allowing them to detect early signs of deterioration before symptoms are noticeable.
“The Loop System uses optical sensors located on a wristband to measure pulse oximetry, respiration rate and heart rate. This simple-to-use wearable doesn’t require any input or data from patients and does not require a smartphone or app,” said Elad Ferber, co-founder and CTO of Spry Health. “The vital signs we measure are especially relevant for patients with COPD, because changes in respiration rate and blood oxygen are indicative of a deterioration.”
Designed for use by healthcare systems, the Loop System can effectively monitor patients with COPD, a serious lung disease that over time makes it hard to breathe. COPD is the third leading cause of death in the United States, claiming more than 120,000 American lives each year. More than 12 million have been diagnosed, but another 12 million are likely to have COPD and don’t know it.
“This FDA clearance is an exciting milestone for Spry Health. We are thrilled to bring our technology to healthcare providers and patients to make a positive impact on managing COPD, one of the most challenging problems in healthcare today,” said Pierre-Jean “PJ” Cobut, co-founder and CEO of Spry Health. “We believe this technology holds the potential to not only improve health and reduce costs but also to provide reassurance and peace of mind for patients and caregivers.”
Spry Health has demonstrated the efficacy of the Loop System through extensive clinical validation studies with University of California, San Francisco (UCSF). During a pilot study with a major health system to remotely monitor COPD patients with the Loop, interim results demonstrate that 92 percent of patients wearing the Loop followed their doctor’s monitoring recommendations, comparing favorably to the 20 percent rate deemed an industry success using other monitoring tools.
Peer-reviewed studies have demonstrated that capturing data among COPD patients can identify and predict exacerbations. Now, this capability is available commercially for the first time via the Loop System.
The Loop is commercially available in the U.S and is offered by physicians and health systems to their patients.