We Listened to You: Meet the Monitor of the Future.
September 29, 2023
Mark I. Darrah, Ph.D.
CEO/President
Athena GTX, Inc., Johnston, Iowa, is very pleased to announce FDA submittal today, 29 September 2023, for medical clearance to market of an extraordinary new family of mobile medical monitors in response to a growing demand for innovative solutions to an expanding global market. The new Wireless Vital Signs Monitor- Professional Version (WVSM®-Pro™) is the next generation of the WVSM® and will be compatible with our own FDA-cleared ADMS®, and other MDDS software platforms (such as BatDok) in iO/S, Android and PC variants.
Athena GTX’s CEO, Mark I Darrah, Ph.D. reports that “our wireless monitoring solutions revolutionize our customer’s options for deployment and changing demands in a very smart platform. These devices know what is connected to them and the monitor displays adapt automatically”. Since 2010, our monitor developments and innovative technology advancements have been cooperatively supported under contracts and CRADA from MEDCOM USAMMA, USN Office of Naval Research (ONR), HQSOCOM, NAWCADPAX, US Congressional Support, and the National Trauma Center (NTC) in Texas. Sales continue worldwide for the FDA-cleared WVSM® and are expected to increase dramatically now with the next iteration of the proven baseline system, once FDA-cleared.
The Global Market for mobile medical devices used in monitoring and diagnostics is projected to reach $70 billion by 2029. It is expected to grow at a double-digit compound annual growth rate (CAGR) of 26.5% over the forecast period. This growth is driven by the easy availability and adoption of enhanced mobile communication services worldwide. (Source: June ‘23 by iHealthcareAnalyst, Inc.). The core value of the solution is embracing faster and more efficient care of patients in a highly mobile miniature monitor that adapts to needs. The increasing prevalence of chronic diseases such as cardiovascular and respiratory diseases, hypertension, diabetes, and increased demand for home-based portable monitoring devices in both the developed and developing countries boosting the growth of the mHealth monitoring and diagnostic devices market. Healthcare professionals are increasingly adopting mobile medical applications such as smart phones, tablets and watches now for information and time management, health record maintenance and access, communications and consulting, reference and information gathering, patient management and monitoring, clinical decision-making, medical education, and training. The next step in the WVSM-Pro future is clearance of our new ADMS connectivity software and adding decision support and the use of Artificial Intelligence (AI). Athena remains extremely excited about the future of wireless connectivity in lightweight, mobile, smart medical monitoring devices.
About Athena GTX, Inc. Athena is a small business focusing on innovative R&D and transitioning the best discoveries into medical products for first responders worldwide; both civilian and military with multiple trademarks, patents and FDA clearances to date. Athena’s core focus is mobile wireless monitoring, wearables and smart systems coupled to validated algorithms and custom connectivity software to determine patient state from incoming data/information. Current ongoing innovations nearing FDA clearance submittals include a miniature suitcase ICU, an underwater monitoring solution for divers, and others. For more information, please see our website at www.athenagtx.com.
Approved for Public release, 29 Sept 2023
WVSM Pro is considered an investigational device. All safety, effectiveness, or performance statements made are subject to changed based on FDA 510k submission/pending PMA, not available for sale.
______________________