Strados Labs announced that its RESP Smart Sensor Platform, which remotely measures and records lung sounds for use in respiratory disease treatment and clinical trials, has been granted a CE mark. According to Strados, a number of clinical trial sponsors are using measurements made by the RESP system as endpoints in studies of drugs in development for the treatment of respiratory diseases. The RESP platform received 510(k) clearance from the FDA in December 2020.
According to Strados, “RESP captures lung sounds and breathing patterns to assist in building robust and accurate depictions of patient’s pulmonary sounds using patent-pending algorithms—aiding in potentially predicting and avoiding pulmonary failure events that are costly and life threatening.”
Strados CEO and co-founder Nick Delmonico commented, “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.”
Delmonico added, “With this CE Mark, we will now be able to market and sell our RESP Smart Sensor Platform in EU member countries that accept CE marked medical devices. This opens the door for us to truly impact the lives of so many individuals in other parts of the world who need our respiratory technology. Europe’s adoption of smart sensor technology is out-pacing the US, and the time is now for Strados Labs to step in with our smart sensor platform solution that arms both physicians and patients with more than just data from our respiratory health engines, but knowledge around how to use the data to predict, intervene and avoid non-favorable health episodes.”
Read the Strados Labs press release.
