Envello Medical Receives Prestigious International Award Recognizing Standout Digital Health & Medical Technology Products and Companies

RICHMOND, Va. --(BUSINESS WIRE)

Envello Medical, a subsidiary company of NIRSense, today announced that it has been selected as winner of the “Best IoT Healthcare Wearable Device” award in the 9th annual MedTech Breakthrough Awards program conducted by MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global digital health and medical technology market.

Envello Medical’s Envello Core is the first small, scalable, non-invasive, near infrared spectroscopy (NIRS)-based tissue oximeter with broad potential applications in monitoring of high-volume chronic diseases. The initial and most acute application of Envello Core will be the early detection of cardiogenic shock in patients with heart failure (HF) and ST-segment elevation myocardial infarctions (STEMIs). Envello is being designed for continuous perfusion monitoring that can be employed by any HCP in any clinical setting and hospital-at-home care.

“Cardiovascular disease is the leading cause of civilian mortality. There is currently no tool to directly measure perfusion in a way that can be scaled for the large number of patients with cardiovascular disease. So we introduced Envello Core,” said Casey Boutwell, PhD, MBA, CEO of Envello Medical. “We’re grateful to MedTech Breakthrough for recognizing our important work. But this is just the beginning as we continue to develop a full suite of multi-modal hemodynamic profiling sensors for improved monitoring of patients at every stage of their journey, from the presentation of symptoms to discharge.”

The MedTech Breakthrough Awards program celebrates excellence and innovation in the health and medical technology industry, recognizing the companies, products, and solutions driving meaningful progress and improving patient care. The awards highlight groundbreaking work that is transforming the healthcare landscape.

“Envello Medical’s technology is taking aim at improving patient outcomes while reducing footprint and costs,” said Steve Johansson, managing director, MedTech Breakthrough. “Envello is offering the ability to perform continuous, real-time tissue oxygen monitoring, identifying tissue perfusion trends that may help detect declining health earlier, including reduced cardiovascular performance, and lead to earlier treatment and disease management. Congratulations on winning the ‘Best IoT Healthcare Wearable Device’ for 2025!”

Envello is currently in collaboration on a number of clinical trials, and the company plans to submit Envello Core for FDA 510(k) clearance.

About Envello Medical

Envello Medical is a subsidiary company of NIRSense, a medical device company founded in 2018 that was contracted by the Department of Defense to help protect the health of U.S. warfighters.

Envello is focused on the design, development, and commercialization of innovative scalable, non-invasive monitoring technologies with the potential to improve patient outcomes while reducing footprint and costs. Envello is initially focused on continuous monitoring of tissue oximetry in patients at risk of cardiovascular conditions including heart failure and ST-segment elevation myocardial infarction (STEMI). Envello Core is not yet 510(k) cleared by the United States Food and Drug Administration and is not yet for sale.

About NIRSense

NIRSense is a medical technology company focused on developing world-leading wearable systems. Our tools measure oxygenation changes in the body 10x deeper than pulse oximetry and measure the electrophysiological activity of muscles and the brain. We support a wide range of interested stakeholders who are driven to transform the way humans understand and interact with their own health.

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