The US Food and Drug Administration (FDA) has granted a second 510(k) clearance to expand the use of Respiree鈥檚 RS001 cardio-respiratory wearable to home-based settings.
The clearance includes approval for the company鈥檚 1Bio connected care platform, which leverages data from electronic health records (EHR) and its FDA-cleared, US-patented sensors for tracking the progression of the disease longitudinally.
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The RS001 links to a cellular hub, facilitating the real-time visualisation of data through the 1Bio dashboard.
The company previously secured the 510(k) clearance for the wearable in March 2023.
The RS001 is designed to be worn on the chest, measuring respiration directly and providing cardio-respiratory monitoring.
It is particularly beneficial for individuals with cardio-pulmonary diseases such as congestive heart failure and chronic obstructive pulmonary disease (COPD).
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By GlobalDataRespiree founder and CEO Dr Gurpreet Singh said: 鈥淩espiration is the most predictive vital sign for clinical deterioration, yet it remains underutilised 鈥� particularly outside hospital settings.
鈥淭his 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.鈥�
After recently securing $11.6m in Series A financing, Respiree is gearing up for further development towards regulatory clearances and expansion into global markets.
The company also intends to pursue further clearances from the FDA for its AI software, with plans to integrate AI models into the 1Bio platform for both inpatient and at-home care.
Respiree’s products are available in the US, Australia, and the Asia-Pacific region. The products have secured CE marking and regulatory approvals from Australia’s Therapeutic Goods Administration.
The company鈥檚 current offerings include scalable AI modules that are device-agnostic and platform-independent, pathway-management modules that automate standardised care pathway delivery, a centralised platform compatible with various EHR environments, and connected wearables with adjustable settings for different applications, capable of capturing a comprehensive range of cardio-respiratory metrics.
