FDA Clears Circadia Health’s C100 System for Contactless Respiratory Monitoring

Circadia Health has received expedited FDA clearance for Contactless Respiration Rate (CResp) monitoring due to COVID-19. The C100 System uses radar to sense wirelessly, from up to 4 feet away in adult patients. Continuous CResp will support clinicians and save patient lives, by predicting and preventing respiratory complications through early warning scores, enabling timely interventions. The C100 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.
 
Respiratory rate is routinely measured manually, through visual counting of breaths per minute by nursing staff, and is one of the earliest signs of patient deterioration. However, staff shortages result in this parameter being frequently measured incorrectly or not at all. 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). 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.
 
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. In addition to physiological monitoring, the C100 also offers ambient sound and light monitoring for detecting disturbances and coughing.
 
Dr. Guy Leschziner, chief medical officer of Circadia, said, “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.”
 
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.
 
Fares Siddiqui, Co-founder and CEO of Circadia, said, “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.”
 
Headquartered in London and founded in 2016 by Imperial College London alumni Fares Siddiqui and Michal Maslik, Circadia’s mission is to enable early detection of respiratory failure, the third leading cause of death. Circadia employs engineers, scientists, and physicians to fuse wireless sensors, medical software, and clinically validated algorithms to save patient lives.