TMCnet News
LifeLens Technologies, Inc. Announces 510(k) Clearance of Expanded Vital Sign Monitoring Indications for the LifeLens Physiological MonitorIVYLAND, Pa., July 16, 2026 /PRNewswire/ -- LifeLens Technologies, Inc. (LifeLens), today announced the latest FDA 510(k) clearance for the company's Wearable Physiological Monitoring system. The clearance adds blood oxygen saturation (SpO2), heart rate (HR), respiration rate (RR), heart rate variability (HRV), skin temperature and wellness parameters including activity, body position, step count and gait analysis to its existing FDA 510(k) clearance for ECG acquisition. This combination of vitals monitoring brings the company another substantial step forward in delivering on its unique vision to create proven clinical-grade information that can improve clinical decision making, patient outcomes, and operational efficiencies. LifeLens' physiological monitoring platform is designed to address today's most challenging gap in healthcare: silos of clinical information. The company's platform allows for an extensive range of reliable data acquisition and communication capabilities, packaged in an extremely compact, durable, and comfortable form factor. It provides a potential solution for the persistent issues of data breadth and availability, and low physician confidence in data quality and accuracy. "Managing complex disease requires monitoring solutions that deliver the breadth of clinical, environmental, and contextual data needed to make informed treatment decisions" says Landy Toth, founder and CEO of LifeLens. "But breadth alone isn't enough, the data has to be trusted. This clearance, along with multiple actively enrolling clinical studies, reflects our commitment to closing that confidence gap with clinical validation and FDA regulatory review. We're building the evidence base that turns continuous physiological data into meaningful clinical insight." The FDA clearance represents an important milestone in the company's development efforts to date. Dr. Robert Schwartz, of the Minneapolis Heart Institute Foundation an LifeLens Medical Director, states, "Securing this clearance validates LifeLens' technology for accuracy, safety, and clinical applicability. Moreover, the clearance also gives us confidence that the company is on a solid path for important applications. " Since 2021, the technology behind LifeLens' physiological monitoring platform has been tested by the U.S. military in over 50 fielding events. During this time, the platform has helped military leaders to monitor clinical-grade vital signs, mitigate heat and musculoskeletal injuries, and determine unit readiness in real-time training and operational environments in the most extreme conditions on earth. LifeLens anticipates maximizing the value of this experience by continuing to innovate its platform to address the requirements of civilian healthcare. For more information about LifeLens' physiological monitoring platform, please visit www.lifelenstech.com ABOUT LifeLens, a private healthcare company founded in 2016, has developed a system capable of acquiring extensive physiological, environmental, and contextual data to assess real-time health status and performance. With its comprehensive communications and visualization capabilities, the LifeLens platform is designed to provide actionable information, where and when it is needed, supporting health professionals in making data-driven decisions that improve the health and welfare of patients. Indications for Use The LifeLens Physiological Monitor is intended for spot-check monitoring and continuous storage of physiological data in home and healthcare settings. Data could include ECG, oxygen saturation of arterial hemoglobin (SpO2), heart rate (HR), heart rate variability (HRV), skin temperature (TEMP), respiration rate (RR). Data are securely transmitted from the device for storage, review, analysis, and display. Data from the device are intended as an aid to diagnosis, disease management, and treatment. The device is intended for use on adults (18 years of age or older). The LifeLens Physiological Monitor also reports wellness data including activity level, body position, step count, and gait analysis. Forward looking statements This press release contains "forward-looking statements" concerning the development of LifeLens Technologies, Inc. products, their potential benefits and attributes, and the company's expectations regarding its prospects. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. LifeLens Technologies, Inc. undertakes no obligation to update these statements as circumstances change. Media Contact Jesse Roy 877-656-8550
SOURCE LifeLens Technologies, Inc. 
|
View original content to download multimedia: