Therapy Areas: Respiratory
Strados Labs receives CE Mark for RESP Smart Sensor Platform
19 November 2021 -

Strados Labs, a US-based medical technology company, announced on Thursday that it has received a CE Mark for its RESP Smart Sensor Platform for respiratory health, first-of-its-kind smart sensor platform, measuring and recording, lung sounds remotely across a diverse mix of healthcare settings.

The CE Mark enables the company to work with its customers on global research projects and in global markets. The platform is claimed to offer clinicians a cost-effective, non-invasive, and wireless solution that helps in early and remote detection of key changes in lung acoustics and respiratory patterns of patients. The firm received its FDA Class II 510(k) approval for the RESP in December 2020.

Nick Delmonico, Strados Labs co-founder and CEO, said, 'Being granted this CE Mark in less than a year from receiving our FDA Class II 510(k) clearance for our RESP Smart Sensor Platform is a significant achievement for Strados. Our large pharma clients have many trials underway or planned in Europe, and this allows us to work with our customers on global research projects and in international markets. I'm incredibly proud of our team and how hard they've worked to get us to this next significant milestone.'

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