Spry Health, a provider of health management technologies, has secured approval from the US Food and Drug Administration (FDA) for its Loop system, which measures pulse oximetry, respiration rate and heart rate.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
Loop is said to be the first clinical-grade wearable device that enables clinicians to remotely monitor their patients with chronic diseases such as chronic obstructive pulmonary disease (COPD).
The new system helps clinicians to detect early signs of deterioration before symptoms are noticeable.
Spry Health co-founder and CTO Elad Ferber said: “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.”
The Loop system, which has been designed for use by healthcare systems, can efficiently monitor patients with COPD, a serious lung disease.
The system comes with an analytics software platform for early identification of chronically ill patients who require care.
The system provides significant insights to healthcare teams by continuously collecting pulse oximetry, respiration rate and heart rate, enabling to avoid hospital admissions and reduce healthcare costs.
Spry Health said it has showed the efficacy of the Loop System via 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, the interim results showed that 92% of patients wearing the Loop followed their doctor’s monitoring recommendations.
Peer-reviewed studies have also showed that capturing data among COPD patients can identify and predict exacerbations.
Spry Health also noted that the Loop system is commercially available to the physicians and health systems in the US.
Spry Health co-founder and CEO Pierre-Jean Cobut said: “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.
“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.”