FDA Gives Marketing Clearance to Loop Wearable Wristband that Remotely Monitors COPD Patients

The Loop wristband device, designed to remotely monitor the condition of patients with chronic diseases such as chronic obstructive pulmonary disease (COPD), received marketing clearance from the U.S. Food and Drug Administration (FDA), announced the device’s developer, Spry Health.

Loop is a wearable technology that measures pulse oximetry (oxygen saturation in the blood), respiration rate, and heart rate through its optical sensors. Connected to a software platform that analyzes the data, the device allows clinicians to monitor the condition of patients remotely, and detect early signs of worsening disease, before symptoms are noticeable.

Early detection of symptoms can help healthcare teams to decide when hospital admission is necessary, and hence reduce healthcare costs.

“This simple-to-use wearable doesn’t require any input or data from patients and does not require a smartphone or app,” Elad Ferber, co-founder and chief technology officer of Spry Health, said in a press release.

“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,” Ferber added.

According to studies on COPD patients, oxygen saturation, respiration rate, and heart rate are all parameters predictive of exacerbation events.

Spry Health, together with the University of California, San Francisco, showed the efficacy of the Loop technology in extensive validation studies.

Furthermore, a pilot study on user engagement with Loop showed that 92% of patients followed their doctor’s recommendation, and wore the monitor every day for at least three hours (20% is considered a success rate with other monitoring tools).

“This FDA clearance is an exciting milestone for Spry Health,” Pierre-Jean Cobut, co-founder and CEO of Spry Health, said. “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.”

“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,” Cobut added.

The FDA clearance allows the Loop device to be commercially available in the U.S. through physicians and health systems.