FDA grants 510(k) clearance to contact-free remote patient monitoring device

The FDA granted class II 510(k) clearance to Sleepiz One+, a contactless remote patient monitoring device that tracks respiration rate, heart rate and movement while at rest, according to a manufacturer-issued press release.

With 99% accuracy in detecting breathing rate and 96% accuracy for heart rate, Sleepiz One+ (Sleepiz) is intended to be placed near the bedside to track macro- and micro-motions from heart contractions, breathing patterns and body movements of patients with chronic medical conditions and respiratory diseases in order to extract their vital signs and potentially detect early signs of deterioration, according to the release.

The device, which uses a “MedTech-centric platform” from Essenvia, is intended for both short- and long-term respiration and heart rate monitoring and can help allow for timely interventions and assist in physician decision-making, the company said.

According to the release, physicians can be reimbursed for their time monitoring patients with the device using current procedure terminology codes for remote patient monitoring, requiring compliance with measurements from 16 out of 30 days.

“Sleepiz One+ shifts us from a wired, wearable world to a completely wireless, continuous standard of care,” Soumya Sunder Dash, PhD, cofounder and CEO of Sleepiz, said in the release. “With this FDA 510(k) clearance, Sleepiz has achieved a critical milestone in the highly regulated medical device market. This is just one more step towards creating the future of health care.”