FDA Cleared MedTech Respiratory

Circadia Health’s contactless respiration rate monitor receives 510(k) clearance

London-based startup Circadia Health announced Thursday that it has received an FDA 510(k) clearance for its C100 System, a bedside device to measure respiration rate via radar in adult patients up to four feet away.

Circadia said in its announcement that the C100 system will be launching “immediately” in light of the high demand for respiratory-related illness management. The startup is aiming to deploy the tool in care settings such as hospitals and skilled nursing facilities as well as for at-home health monitoring.

Alongside the respiratory sensor, the system includes a cloud-based software component for care teams to track their patients and receive mobile alerts. The company’s announcement and website also details motion, presence and sleep-quality monitoring capabilities, as well as algorithms for the early detection of adverse events, disturbances or 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,” Dr. Guy Leschziner, chief medical officer for Circadia, said in a statement.

Circadia said that it will be employing subscription model with no upfront costs for its device, and notes reimbursement revenue of $123 per patient, per month, under billable CPT codes.

WHAT’S THE IMPACT?

In early April, Circadia noted in a release that it had already put together plans to begin launching its C100 system in “a large hospital in Los Angeles” and other areas. In particular, the company said that it was pursuing an “expedited review” of its technology from the FDA, and cited the heightened demand for a flexible respiration-rate monitor in the midst of an emerging respiratory infection pandemic.

“Our goal is to provide a frictionless solution to clinicians in order to help improve patient outcomes and reduce the cost of care,” Fares Siddiqui, cofounder and CEO of Circadia, said in a statement. “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.”

THE LARGER IMPACT

The FDA has rolled out the red carpet for remote vital-sign monitors such as respiration rate and breathing frequency.

Case in point: The agency announced a policy in late March that expanded the use of these products throughout the duration of the COVID-19 public health emergency. This decision allowed approved software- and hardware-monitoring tools to be used remotely – a particular advantage for hospitals facing a high volume of patients.

The value of remote monitoring technologies is being recognized by patients as well. A recent Sony study found that 61% of survey chronic-disease patients said they would feel safer during the COVID-19 pandemic if they had a remote-monitoring device provided by their doctor.

Original Article: (https://www.mobihealthnews.com/news/circadia-healths-contactless-respiration-rate-monitor-receives-510k-clearance#)

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