FDA Clears Body-Worn ECG Monitor

Cardiac arrhythmia specialist company, Cardiac Insight, Inc., has received US FDA 510(k) clearance for its Stealth™ body-worn ECG monitor.


Founded in 2008, Cardiac Insight is focused on the development of products to enable the early detection of heart disease and related conditions. Its core technology utilises proprietary technology, licensed from the University of Washington.

The Stealth™ device is a lightweight, adhesive, low power, disposable monitor designed to be worn by patients for an entire day. The device enables diagnostic-quality ECG recordings and is form fitting to the patient’s anatomy.

The monitor provides both doctors and patients with the potential for an improved experience, ease of use and speedier results. The Stealth™ device cleared by the FDA will be the platform for the company’s future devices.

Company comments

“Early diagnosis and treatment of conditions such as atrial fibrillation will reduce the costs associated with acute care of unexpected strokes and cardiovascular disease,” said Brad Harlow, CEO and Co-Founder of Cardiac Insight. He went on to say, “We will continue to work on the development of a highly accurate atrial fibrillation monitor to address the “silent” a-fib market, those patients with undiagnosed, difficult to detect atrial fibrillation, followed by other arrhythmias.”

Source: Cardiac Insight, PR Web