FDA clears Spry's Loop wearable for at-home COPD monitoring

The FDA has cleared a new, clinical-grade wearable from Spry Health. The 2018 FierceMedTech Fierce 15 company’s Loop wristband system is capable of remotely measuring heart rate, respiration and pulse oximetry, and is designed for patients with chronic obstructive pulmonary disease.

“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 chief technology officer of Spry, which hopes to help physicians spot the early signs of deterioration before more obvious symptoms appear by using optical sensors and an analytics software platform.

“The vital signs we measure are especially relevant for patients with chronic obstructive pulmonary disease, because changes in respiration rate and blood oxygen (i.e., pulse oximetry) are indicative of a deterioration,” Ferber said in a statement.

According to Spry, COPD is the third-leading cause of mortality in the U.S., with more than 12 million diagnoses and over 120,000 related deaths annually. Now commercially available, the Loop is designed for health systems to help reduce hospital admissions.

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But while there are many products aimed at remote patient monitoring, compliance rates among people with chronic diseases remains low. Many people with devices at home don’t seem to be using them.

The Loop wristband, however, looks like any consumer-oriented fitness or activity tracker and is comfortable enough to wear all day long, CEO Pierre-Jean “PJ” Cobut told FierceMedTech earlier this year.

“It’s not something that stigmatizes you as a sick person,” Cobut said. “What we’ve decided to do is basically center the experience around the patients first.”

In a pilot study involving COPD patients, interim results showed 92% of patients wore the noninvasive Loop device according to their doctor’s recommendations, Spry said, while other studies have demonstrated that the gathered data can help identify and predict COPD exacerbations.