Strados Labs, a medical technology company using smart sensors to aid in early detection and predictions of worsening diseases for enhanced patient care, has been granted a CE mark for the company’s RESP Smart Sensor Platform for respiratory health.

With this smart sensor platform, measuring and recording, lung sounds remotely across a diverse mix of healthcare settings (e.g., hospitals—in- and out-patient, clinical trials, research and nursing homes) is possible—enabling the identification of abnormal breathing patterns anywhere and at any given time.

Nick Delmonico, 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.”

Strados Labs works with pharmaceutical companies and research organisations to capture lung sound measurements as primary and exploratory endpoints to support key drug trials with its RESP Smart Sensor Platform. The need for understanding how treatments and therapies impact patient respiratory symptoms objectively is paramount. The company’s patient-reporting outcomes (ePRO) from the use of RESP aid sponsors in capturing this information to inform drug development that improves patient outcomes. Minimising patient burden, maintaining patient privacy, and decentralising trial data collection to optimise recruitment and retention are all measurements that can be taken from RESP to align with sponsor goals.

Wessel van Dijik, medtech business consultant, WEMAconnect BV, said: "The increasing number of patients with COPD and multi-morbid chronic conditions requires an integrated personalised approach to support and managed care. Currently, 75% of all adverse events and preventable deaths occur outside the ICU in un-monitored beds. Strados Labs' RESP Smart Sensor Platform for respiratory health is the next-level technology for patients diagnosed and/or impacted by lung disease. I believe it will significantly add value as a remote monitoring system for healthcare systems, provide lung disease management and will greatly benefit patients in Europe."

The RESP Smart Sensor Platform provides clinicians a cost-effective, non-invasive, and wireless solution that aids in early and remote detection of key changes in lung acoustics and respiratory patterns of patients. Its cloud-based system easily integrates with existing clinical workflows and can be billed under CPT codes for RPM and Telehealth. 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.

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 U.S., 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-favourable health episodes.”