CE Mark expands the company’s reach to support customers on a global scale
Philadelphia, PA, November 18, 2021 – Strados Labs, a medical technology company harnessing the power of smart sensors to aid in early detection and predictions of worsening diseases for enhanced patient care, announced today it was granted a CE Mark for the Company’s RESP™ Smart Sensor Platform for respiratory health.
Currently, there are no convenient or simple ways to capture abnormal patient lung sounds and patterns remotely. With this first-of-its-kind 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.
“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,” said co-founder and CEO Nick Delmonico. “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 organizations 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. Minimizing patient burden, maintaining patient privacy, and decentralizing trial data collection to optimize recruitment and retention are all measurements that can be taken from RESP to align with sponsor goals.
“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,” said Wessel van Dijik, medtech business consultant, WEMAconnect BV. “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.
“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,” continued Delmonico. “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-favorable health episodes.”
Strados Labs received its FDA Class II 510(k) clearance for the RESP in December 2020. The CE Mark designation is the next significant step as the Company is developing a robust pipeline of other smart sensor platforms to support and address other chronic diseases, as well as chronic disease management. The Company will continue to target COPD and infectious diseases (COVID, RSV, etc.) as it moves into 2022 and will add heart failure in late 2022.
About Strados Labs
Strados Labs is a medical technology company harnessing the power of smart sensors and AI to provide early detection and predictions of worsening diseases for enhanced patient care.
Strados Labs developed its flagship and first-of-its-kind smart sensor platform for respiratory health, RESP™. The cloud-based engine and smart sensor aids in early and remote detection of key changes in lung acoustics and respiratory patterns of patients. It also acts as an extension of care team’s—reducing clinician to patient contact, integrating with existing clinical workflows, pairing lung sounds and breathing patterns to build robust and accurate depictions of patient’s pulmonary sounds using patent-pending algorithms. RESP™ also has the potential to help predict and avoid pulmonary failure events that are life threatening and costly. RESP™ is used in respiratory clinical trials to capture lung sound measurements data as primary and exploratory endpoints. Healthcare systems and settings (e.g., hospitals—in- and out-patient, clinical trials, research and nursing homes) use it to enhance patient care, provide continuous monitoring, collect respiratory data, while reducing readmissions and providing cost-savings. For more information, visit: stradoslabs.com