Respiree Secures Second FDA 510(k) Clearance, Expands Cardio-Respiratory Wearable to Home Use via 1Bio™ Connected Care Platform
HOUSTON and SINGAPORE, Aug. 05, 2025 (GLOBE NEWSWIRE) — Respiree, a health tech company developing artificial intelligence (AI) platforms to manage disease progression across the healthcare continuum, today announced it has received its second U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance expands the use of its RS001 cardio-respiratory wearable to home environments and includes approval for its connected care platform marketed as 1Bio™.
Illustrative Image of Respiree's RS001 Wearable With its Connected Care 1Bio™ Platform
The RS001 is a chest-worn device that directly measures respiration and offers passive cardio-respiratory monitoring. Originally cleared for in-patient clinical use, the RS001's use in home settings marks a significant step toward more accessible and preventive healthcare. The device connects to a cellular hub, which enables data to be visualized in real time via the connected care 1Bio™ dashboard.
'Respiration is the most predictive vital sign for clinical deterioration, yet it remains underutilized – particularly outside hospital settings,' said Dr. Gurpreet Singh, CEO and Founder of Respiree. '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 announcement follows Respiree's recent US$11.6 million Series A financing round, led by We Venture Capital and ClavystBio, which will accelerate development toward potential regulatory approvals and global market expansion. Respiree also announced plans to pursue additional FDA clearances for its proprietary AI software, aiming to integrate artificial intelligence models into the 1Bio™ platform for both inpatient and home-based care.
'These are exciting times for us,' added Dr. Singh. '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).'
About Respiree
Respiree™ is an AI/ML health tech company building state-of-the-art clinically-validated artificial intelligence (AI) for managing disease progression across healthcare's care continuum. The 1Bio™ platform by Respiree™ uses data from the EHR and its proprietary US-patented and FDA-cleared sensors to longitudinal measure and track disease progression. Respiree™ is now available in U.S., Australia and Asia-Pacific (APAC). Respiree™ is CE marked, has received regulatory clearances in Australia from the Therapeutics Goods Administration and has received the 510k clearance from the United States Food and Drug Administration (FDA). (www.respiree.com)
Media Enquiries
Evangeline Fu
Administrative Manager
Respiree Pte Ltd
Email: [email protected]
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/aea7197c-89ac-4dbb-82b9-da85e7dd07f8
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