San Francisco-based AliveCor announced that the FDA has granted its smartphone-enabled, single-channel ECG (electrocardiogram) recorder device over-the-counter (OTC) clearance. The company is now taking direct-to-consumer preorders for the device at a $199 pricepoint. It expects to begin shipping them in early March. Up until now the AliveCor device has only been made available to physicians and other medical professionals, who could also prescribe them to their patients.
The device, which takes the form factor of either a smartphone case or a peripheral that attaches to the back of the phone, enables users to record and share their own ECGs. AliveCor works with both Android and iOS devices now and was first cleared by the FDA for iOS devices in late 2012. Last year the company received clearance for its Android-compatible device in October.
Over the years the company has described a number of potential users for the device. Primarily, it could help patients who feel like they have a heart arrhythmia problem, but are asymptomatic and it doesn’t show up when they visit their doctor’s office. This device can be at the ready if the patient has it with them, and it can be used to record the heart rhthym strip the next time the patient feels something. Another use case is for someone who has already been diagnosed with atrial fibrillation and has been treat with ablation and/or medications. A physician could prescribe the device for at-home use so that they could monitor the patient remotely and determine whether the therapy they had also prescribed was effective or is working. The device is also a preventive medicine tool since it detects arrhythmias, which can be a problem in and of themselves sometimes but can also be associated with something else — like an imminent heart attack. Update: As made clear in the comments below, the company, however, does not sell the device as something that is intended to diagnose a heart attack -- imminent or in-process.
AliveCor users based in the US can share their recorded ECGs with their physician or they now have the option of sending the reading to either a remote cardiologist or a remote cardiac technician via the new direct-to-consumer service, called AliveInsights. Each time a user sends their ECG for analysis they have to pay a fee. AliveCor users in the UK or Ireland (the other two markets where it is currently available) do not have access to AliveInsights.
The cardiac technician review is offered to AliveCor users thanks to a partnership the company has with eCardio. AliveCor describes the analysis like this: "A technical review sends your ECG recording to a US based Cardiac Technician who will send you a report within 30 minutes or 24 hours depending on the level of service you choose. This report contains preliminary findings along with their related definitions."
The board-certified cardiologist review is available to AliveCor users because of a partnership with CompuMed: "AliveCor’s Clinical Review, performed by a US Board-Certified Cardiologist, returned within 24 hours, provides a more in-depth report including severity level with recommendations and findings."
AliveCor first launched these services in November and at the time it explained pricing as follows: Reviews will be available 24/7 for what the company called a “minimal fee.” The cardiologist will run patients $12 and is powered by CompuMed. The cardiac technician option, powered by eCardio, costs $2, or patients can pay $5 to get their report within 30 minutes. Otherwise, the company promises a 24-hour turnaround. Patients can share their interpretations with their personal physician via the app.
AliveCor stresses in its "terms of service" agreement with users that the remote analysis its partners provide is not a diagnosis: "The interpreted report is intended as information for you and to be used as a tool for your physician to provide proper diagnosis and treatment taking into account your complete medical history. Analysis and diagnosis based on your data can only be accomplished by your physician. It is your responsibility to present your medical data to your physician for proper analysis and diagnosis."
The company also makes "no guarantees of the accuracy or clinical significance of the interpretation of your data" and notes that "your physician may disagree with the interpretation of your data."
Perhaps the most notable language in AliveCor's terms of service is its policy on state-by-state telemedicine laws: "Due to telemedicine restrictions, your location may restrict your ability to use the clinical interpretation service. Since you are using a mobile device to collect your data, AliveCor does not know your location; it is your responsibility to ensure the clinical interpretation service is legal according to your local telemedicine laws."