AliveCor has received FDA clearance for its mobile heart monitor, allowing it to open pre-sales for the device in the United States.

The company says it will ship its $199 iPhone-connected heart monitor in early January 2013. The device incorporates electrodes into a case that snaps onto the back of Apple iPhone 4 and 4S smartphones. With a corresponding app, it can be used to record heart rate or the electrical impulses of the heart to create an electrocardiogram, or ECG.

In a presentation to the 2012 American Heart Association Meeting, a group of company and outside authors called the device “an ideal enabling technology for community screening programs to detect silent atrial fibrillation” and that screening programs using the device “could have a substantial impact on reducing ischemic stroke related to previously undiagnosed atrial fibrillation,” an arrhythmia that carries a five-fold increased risk of stroke.

The heart rhythm records created by AliveCor’s monitor are stored on the user’s iPhone and securely on AliveCor’s web site for later analysis, sharing, and printing. The ECG data is sent wirelessly from the heart monitor via AliveCor’s low-power, proprietary communication protocol, and requires no pairing between the iPhone and the device.

“Our goal is to make health care cheaper, easier and more readily available without losing quality of care,” says AliveCor President and CEO Judy Wade.

The company is initially targeting sales to medical professionals. Doctors have embraced the iPhone in their practice according to statistics from Manhattan Research. More than two-thirds of physicians use an iPhone or other device running Apple’s mobile operating system, iOS, for professional purposes, according to the research firm’s 2012 online survey of 3,015 U.S. practicing physicians.

Veterinarians are receiving their own message from the company, which is promoting the monitor for use in exams and pre-operative screenings for dogs, cats, and horses.

AliveCor is funding its launch and commercialization of the mobile ECG with a $10.5 million Series B financing, led by Burrill & Company, the publisher of The Burrill Report, and new investor Khosla Ventures, as well as Series A investors, the Qualcomm Life Fund the Oklahoma Life Sciences Fund. Before that, the company raised $3 million in Series A financing in August 2011.

AliveCor’s heart monitor does not yet provide diagnosis or analysis. But the rapid adoption of smartphone- and tablet-linked medical devices combined with the power of wireless networking and machine-learning algorithms is rapidly transforming the medical device industry and will certainly converge over time with telehealth initiatives to enable remote analysis and diagnosis.