EPI Mobile Health Solutions, a Singapore-based company, has received FDA clearance for a smartphone-enabled ECG device — one which the regulatory agency refused to import last fall. The company claims on its website to be “the world’s first, patented Electrocardiogram (‘ECG’) function integrated onto a mobile phone,” likely referring to its EPI Life mobile phone offering. EPI Mobile Health has been selling its devices overseas since at least 2011, the same year AliveCor, the first smartphone ECG makers to secure FDA clearance, debuted at CES.
EPI Mobile Health Solutions was cited in an Import Refusal Report by the FDA in September 2012. According to the document, the FDA rejected EPI’s attempt to import its recently cleared device, the EPI Mini, into Seattle, Washington because the company had not yet secured 510(k) clearance at the time.
EPI Mini isn’t a smartphone case like some of its competitors, but rather a separate device that collects ECG readings through the user’s fingertips. The data is sent to the user’s phone via Bluetooth, according to the company’s website. The data is then automatically sent to EPI’s 24-hour health concierge service, which sends an interpretation of the results back to the user via text message. Users who sign up for a subscription service can also store and track their ECG data in a virtual health record they can access online. Up to five different users can be registered on a single device.
The company has had clinical trials published in the journals Heart and European Heart Journal Supplements. In a study of 240 ECG readings from 30 patients, 98 percent of the readings from the EPI’s original device, EPI Life, correlated with readings from a hospital standard 12-lead ECG. EPI Life is a mobile phone with the same ECG-reading method as EPI Mini integrated into it. It’s larger and weighs more than the Mini and takes up to 30 seconds to read a user’s heart rate.
San Francisco-based AliveCor received its FDA clearance in December 2012. It was followed up by Cardiac Designs’ ECG Check app, which received not only prescription but over-the-counter clearance in March. Like AliveCor, EPI is only cleared for prescription use. Like previous clearances, the FDA documents specifically stipulate that the EPI Mini is not a diagnostic device.
According to the clearance document the EPI Mini is “intended for use by adults who suffer from cardiovascular disease, are considered high risk for possible cardiovascular events or are concerned about their heart function and rhythm,” the clearance document says.
The existing competitors in the space have been busy in the last few months as well. Cardiac Designs ECG Check is now available for purchase from their website for $99. Meanwhile AliveCor recently made their device available for iPhone 5 and began selling its device in the UK and Ireland.