[Glasgow, Scotland – Tuesday, 6th May, 2025]
We’re pleased to share that PneumoWave has received Class II FDA 510(k) clearance for our Data Collection Mobile (DCM) system – a significant regulatory milestone that strengthens our position in the digital health and respiratory care markets.
This clearance affirms the depth of our technical, clinical, and regulatory capabilities. Our DCM system – encompassing hardware, software, cybersecurity, usability, and risk management – underwent rigorous FDA scrutiny and was cleared with virtually no objections.
This first US clearance is for sleep and activity monitoring with our Biosensor worn on the wrist; it represents a critical step forward in our broader product development strategy and demonstrates strong regulatory confidence in our engineering and ISO 13485 certified quality system. It’s the foundation we need for our chest-worn system that detects breathing trouble in real time.
We’re proud of the dedication shown by our engineering, clinical, human factors and regulatory teams in achieving this milestone. It reinforces our trajectory toward scalable, real-time respiratory monitoring solutions with potential global impact.
