UW Spinout Cardiac Insight Wins FDA OK for Heartbeat Monitor
[Updated: 3:55 pm PT] Medical device startups often need to live on shoestring budgets as a lot of venture capital has dried up in the wake of the Great Recession, but Bellevue, WA-based Cardiac Insight has proven that you can sometimes come up with innovative new devices for less than $2 million.
The company, a spinout from the University of Washington, has won FDA clearance to start selling a tiny monitoring device that can spot atrial fibrilliation (a-fib), a common form of irregular heartbeat that can lead to stroke. The device, called Stealth, weighs about one-fourth of an ounce, has a flexible circuit board that makes it easy to wear, and uses a proprietary algorithm to read electrocardiography patterns for signs of a-fib, CEO Brad Harlow has said. In a document Cardiac Insight is circulating to investors, the company says it can produce the device for less than $20 per unit.
[Updated with CEO comment] Cardiac Insight, which came from the lab of David Linker, is now tasked with finding a way to scale up, and win a second FDA approval that it intends to get before marketing the product, Harlow said. The market is potentially a big one, as about 2.2 million people in the U.S. are thought to have a-fib, and it leads to an estimated 90,000 strokes a year. The Cardiac Insight device will also have to position itself to compete with San Francisco-based iRhythm, which already markets an a-fib detection device called the Zio Patch.
Cardiac Insight is betting that physicians will like its device because patients can wear it for a week, come back for a visit, and it will spit out heart rhythm results in an automatic report. The company is also seeking partners to develop a similar wearable device that can help spot signs of sleep apnea.
Cardiac Insight’s investors include several well-known names in the medical device community, including Kirby Cramer, the former chairman of Sonosite; Dick Martin, the former CEO of Physio-Control; and WRF Capital.
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How does the data get from the sensor to the world? USB? BTLE?
While the heart monitor is plenty exciting, as an apnea patient, I’m especially excited to see that Cardiac Insight is also working on a wearable apnea detector. With multi-thousand-dollar sleep studies that only provide limited data (one night only, in unfamiliar surroundings), the sleep-medicine industry is ripe for disruption by just such a device. I’ll be keeping an eye on Cardiac Insight for sure!