FDA clears Spry Health’s Loop clinical-grade wearable

Spry Health has received FDA clearance for its Loop clinical-grade wearable for chronic diseases.

The Loop System measure pulse oximetry, respiration rate and heart rate. The clearance allows clinicians to remotely monitor patients who have chronic diseases like chronic obstructive pulmonary disease. The wearable allows for early detection of deterioration before symptoms are noticeable.

“The Loop System uses optical sensors located on a wristband to measure pulse oximetry, reparation 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,” 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 because changes in respiration rate and blood oxygen (i.e., pulse oximetry) are indicative of a deterioration.”

The wearable is designed to be used in a healthcare system to monitor patients.

“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,” Pierre-Jean Cobut, co-founder and CEO of Spry Health, said. “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.”

In peer-reviewed studies, Spry Health’s Loop System has shown that the data is able to identify and predict exacerbations. Another pilot study showed that 92% of patients wearing the device were able to follow their doctor’s monitoring recommendations.