Cardiac Insight, a young company with spin-out technology from the University of Washington, scored FDA 510(k) clearance for its tiny atrial fibrillation monitoring device called Stealth.
The Bellevue, Wash.-based company was incorporated in 2008 and developed Stealth Ambulatory Monitor for less than $2 million, according to reporting by Xconomy.
Stealth was born in Dr. David Linker’s lab at UWash; the device weighs in at 1/4 of an ounce and comes with a price tag of $20 per unit. The company is now looking to scale up production, according to the article.
Cardiac Insight views Stealth as a platform for future devices and the company plans to expand the technology to diagnose conditions other than atrial fibrillation.
"Early diagnosis and treatment of conditions such as atrial fibrillation will reduce the costs associated with acute care of unexpected strokes and cardiovascular disease," CEO Brad Harlow said in a release. "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."