FDA OK for Heartbeat Monitor

Cardiac Insight Inc. officials announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Stealth body-worn ECG monitor.

The Stealth 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.

“Early diagnosis and treatment of conditions such as atrial fibrillation will reduce the costs associated with acute care of unexpected strokes and cardiovascular disease,” states 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.”

The website is not yet fully functional for Cardiac Insight, so to get in touch their number is: 425.818.2175.