FDA gives thumbs-up to latest fingertip EKG
The EPI Mini out of Singapore collects electrocardiogram readings for up to five people through their fingertips and sends the data via Bluetooth to a designated phone.
Every year, more than 700,000 Americans have a heart attack, and more than 600,000 die from heart disease -- that's one in every four deaths in the U.S., according to the Centers for Disease Control and Prevention.
A small crop of mobile electrocardiogram (ECG or more commonly EKG) devices is springing up to meet the needs of those who suffer from heart disease and want to more easily monitor their heart health. The latest, EPI Mobile Health Solutions' "EPI Mini" out of Singapore, has just received FDA clearance in the U.S. after being on the market in parts of Asia for a few years.
An EKG is a test that can measure how fast one's heart is beating, whether it's steady or irregular, and how strong the electrical signals are as they pass through each part of the heart. Traditionally, the tests are performed by doctors in hospitals or clinics using gel and 12 leads, and have the downside of not being able to measure someone's heart activity while in various environments doing various activities.
The EPI Mini aims to help "adults who suffer from cardiovascular disease, are considered high risk for possible cardiovascular events or are concerned about their heart function and rhythm," according to the clearance document. Unlike some of its competition, the Mini is not a smartphone case but rather a separate device that collects ECG readings through the user's fingertips and sends that data via Bluetooth to a designated smartphone. From there, the readings automatically go to EPI's 24-hour health concierge service, which are interpreted and sent back via text.
EPI users can also sign up for a subscription service to track and store their data online, with as many as five users being registered per device.
In clinical trials, 98 percent of the readings from the company's original device, the, match readings from a hospital standard 12-lead EKG. (The Mini uses the same EKG-reading tech but is smaller.)
Like one of its main competitors, AliveCor, which received FDA clearance in late 2012 and is now available in the U.S. for $199, EPI Mini is cleared for prescription use only. Another competitor, Cardiac Designs ECG Check, has been available in the U.S. since May for $99.
No word yet on the Mini's U.S. price tag. When its predecessor, EPI Life, debuted in 2010, it went for $357 in Hong Kong, Singapore, and Malaysia, but it was a standalone cell phone that also required a monthly subscription fee.