Circadia Health has received FDA 510(k) approval for its Circadia C100 Contactless Monitoring System, which uses Contactless Respiration Rate (CResp) monitoring.

The C100 System uses radar to sense wirelessly, from up to four feet away in adult patients. Continuous CResp will support clinicians and save patient lives, Circadia says, by predicting and preventing respiratory complications through early warning scores, enabling timely interventions.

The system features a radar sensor, proprietary radar Signal Analysis Technology (rSAT), and cloud-based software for early detection of patient deterioration to augment clinical decision making.

Contactless respiration rate, CResp, has been shown to be accurate, reliable, easy-to-use, and scalable for both continuous and spot-check monitoring across the continuum of care (general care floors, skilled nursing, and home health), according to Circadia. CResp addresses the known limitations of pulse oximetry and other wearables, offering long-term respiration data effortlessly to enable effective triage and ongoing care management.

Circadia will be launching the C100 immediately to play a critical role in helping hospitals and skilled nursing facilities combat respiratory-related illnesses including COVID-19, pneumonia, COPD exacerbations, and other forms of respiratory failure, in a wide range of patients, both in-hospital and at home.

“Designed for convenience and scalability, Circadia’s aim is for the C100 to become the gold standard for respiratory monitoring. The C100 eliminates patient compliance issues and helps clinicians monitor proactively and remotely to improve patient outcomes, reduce readmissions, and reduce the risk of infection transmission from patient-to-patient and patient-to-clinician,” the company said in a press announcement.

Alongside CResp, Circadia rSAT and AI-powered algorithms offer monitoring of motion, presence, and sleep quality. This facilitates early detection of adverse events such as falls, and recovery analysis, the company says. In addition to physiological monitoring, the C100 also offers ambient sound and light monitoring for detecting disturbances and coughing.

“We are building a ubiquitous data-driven platform, utilizing long-term continuous physiological parameters that we capture using our technology to develop proprietary early warning risk scores for various medical conditions,” said Dr Guy Leschziner, chief medical officer of Circadia.

Fares Siddiqui, co-founder and CEO of Circadia, added: “Our goal is to provide a frictionless solution to clinicians in order to help improve patient outcomes and reduce the cost of care. During this COVID-19 crisis, the FDA has recognized the life-saving potential of our technology. We are now able to deliver the most convenient and powerful method to monitor fragile patients both in-facility and remotely at home.”

Circadia’s Data as a Service (DaaS) model allows the C100 to be available under a subscription model with zero upfront cost to healthcare providers. The C100 generates reimbursement revenue of $123 per patient per month under CPT codes 99454, 99457, and 99458.