Xandar Kardian is making history becoming the first and only company to obtain a broad FDA 510(k) clearance for autonomous continuous monitoring of resting heart rate, respiratory rate, motion and presence for patients in post-acute, home and long-term care settings.
Xandar Kardian's XK300 is the first and only FDA 510(k) cleared device using radar technology to safely obtain RHR + RR + motion data cleared for use in general hospital, nursing homes (all types) and residential homes for home health monitoring. The clearance has given strong validation and credential to the safety and efficacy of the system within a growing competitive market of non-contact health monitoring devices. When compared to traditional vital sign monitoring devices, such as EKG and Co2 mask RR sensors, XK300 technology is a "fraction" of the cost without patient compliance or additional staff time to collect measurements. Reliability is increased since the system is able to automatically filter out noise from motion and only record resting heart rate and resting respiratory rate. Furthermore, the ability to obtain motion data (actigraphy) at the same time means that it can be used in the behavioral and wellness monitoring of activities of daily living.
First, the COVID-19 pandemic has put tremendous strain and stress on staff in both acute and long-term care settings. The technology enables reduced work pressures and automates redundant tasks so staff can focus efforts where they value it most -- providing direct patient care. Secondly, the solution can improve clinical outcomes by automatically detecting early signs of patient deterioration. This may reduce risks to patients, and lower healthcare costs by eliminating unnecessary ED transfers and hospital readmissions. Autonomous monitoring which requires no patient compliance, also simplifies access to existing Medicare Remote Patient Monitoring (RPM) Reimbursement and enables additional access to additional clinical support for patients for patients at home and in long-term care.
Xandar Kardian has prepared a dossier outlining existing clinical evidence outlining the ability to detect patients at risk of deterioration through continuous vital signs monitoring. This includes over 100 studies in acute and post acute settings. The XK-300 has been validated in over 15 peer-reviewed journals (https://www.xkcorp.com/company/journal-publications/) relating to general vital signs monitoring, sleep apnea, behavioral health, NICU, gait analysis, ADHD, and vehicle occupant monitoring. Within the last year, we have launched 5 pilot sites in acute care and long-term care/ SNF, with the intention to validate the economic and clinical ROI in real-world settings. Outcomes from the initial pilot site demonstrated the predictive ability of the XK-300 in detecting deterioration. In one patient, changes in vital signs were detected 3 days prior to acute respiratory distress. https://www.xkcorp.com/company/whitepapers/
