University of Washington Spinout Cardiac Insight Wins FDA OK for Heartbeat Monitor
Published: Jun 07, 2013
Cardiac Insight Receives 510(k) Clearance for Wearable Monitor for Outpatient ECG Monitoring
Bellevue,WA (PRWEB) June 05, 2013- Cardiac Insight, Inc., a company focused on the diagnosis and treatment of cardiac arrhythmias, today 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,” 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.”
About Cardiac Insight:
Founded in 2008 and with general operations underway in June 2010 with financing, the company is focused on the development of products to enable the early detection of heart disease and related conditions. Core technology utilizes proprietary technology licensed from the University of Washington.
The company intends to further develop and commercialize enhanced versions of the monitor specifically for the detection of atrial fibrillation and other conditions.
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