Singapore-based health tech company Respiree has secured the second US Food and Drug Administration (FDA) 510(k) clearance for its cardio-respiratory wearable device, RS001.
The FDA approval widens the application of its RS001 device to home settings, and also includes Respiree’s connected care platform, 1Bio.
RS001 is a chest-worn device designed for passive cardio-respiratory monitoring, directly measuring respiration, and was initially approved for in-patient clinical use.
The platform uses data from electronic health records (EHR) and the company’s unique patented and FDA-approved sensor to measure disease progression.
The expanded approval enables its use in home environments, enhancing its utility.
It allows the users to benefit from real-time data visualisation through a cellular hub connected to the 1Bio dashboard.
With the expanded FDA 510(k) approval healthcare systems are enabled to monitor leading indicators at home passively and accurately.
The enhanced capability facilitates earlier interventions, potentially reducing the overall burden on healthcare infrastructure.
Respiree founder and CEO Gurpreet Singh said: “Respiration is the most predictive vital sign for clinical deterioration, yet it remains underutilised, particularly outside hospital settings.
“This FDA 510(k) extension allows healthcare systems to passively and accurately monitor leading indicators in the home, enabling earlier interventions and reducing the overall burden on healthcare infrastructure.”
The expanded FDA approval follows Respiree’s recent $11.6m Series A financing round, led by ClavystBio and We Venture Capital.
The funding will advance the company’s development efforts towards additional regulatory approvals and global market expansion.
Respiree plans to seek further FDA clearances for its AI software, aiming to integrate these models into the 1Bio platform for both inpatient and home-based care.
Singh added: “These are exciting times for us. Our first 510(k) was for the wearable; this second one is for the platform. We are now focused on bringing our flagship AI models into the fold as a Software as a Medical Device (SaMD).”
