Spry Health Receives FDA Clearance of its Loop System, Designed to Transform COPD Care

Spry Health, a developer of health management technologies and remote patient monitoring, has received U.S. Food and Drug Administration (FDA) clearance to market the company’s Loop System. Loop is the first 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 chronic obstructive pulmonary disease (COPD), because changes in respiration rate and blood oxygen (i.e., pulse oximetry) 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.¹
 
“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.² Now, this capability is available commercially for the first time via the Loop System.
 
The Loop is commercially available in the United States and is offered by physicians and health systems to their patients.
 
The Loop System is the first clinical-grade wearable combined with an analytics software platform for early identification of chronically ill patients who need care. By continuously collecting pulse oximetry, respiration rate and heart rate, the Loop System delivers actionable insights to healthcare teams to avoid hospital admissions and reduce healthcare costs.
 
Spry Health, incubated at Stanford-affiliated accelerator StartX, develops digital health solutions to transform how chronically-ill patients are treated, improve patient outcomes, and dramatically reduce healthcare costs. Founded in 2014 with a vision to transform health solutions, the company creates a new channel of information from patients with COPD through wearable technology. Spry Health provides health care organizations with analytics to allow for better care of their patients, decrease hospital admissions, and reduce unnecessary spending. 

References 
¹ NIH National Heart, Lung and Blood Institute, www.nhlbi.nih.gov/files/docs/public/lung/copd-atrisk.pdf
² PubMed (Internet). J Med Internet Res. 2017 Mar 7;19(3):e69.