Dec 17, 2012 (07:12 AM EST)
Personal Mobile Heart Monitor Gets FDA OK
Read the Original Article at InformationWeek
announced that the company received FDA 510(k) clearance for its mobile heart monitor. The tool, which is technically an iPhone accessory, acts as a typical iPhone case but has integrated electronics, wireless communication and electrodes. When used in conjunction with the AliveCore app, the heart monitor acts as a personal electrocardiogram recorder, allowing physicians to screen for abnormal cardiac rhythms, including atrial fibrillation. The patient records information by pressing fingers from each hand to electrodes on the device, or placing it on the chest.
AliveCore CMO and product inventor Dave Albert, M.D., said in an interview with InformationWeek Healthcare that the tool and app also are connected to a Web service, which allows a physician anywhere in the world to view a patient's ECG results within 10 seconds of them being reported. "So I could be in Africa, and a doctor in San Francisco can view the ECG within that time frame," he said.
Since receiving its FDA clearance, Albert said the company will make the heart monitor available first to medical professionals, and then to patients under prescription. In 2013, he hopes to get clearance once again from the FDA to sell it over the counter. The company also plans to have the tool available for the iPhone 5 in January, with "full production release in March." Albert added that he will make the monitor available for Andriod users either at the end of the first quarter of 2013, or the beginning of the second. The company has demonstrated the tool to Samsung and has it working in prototype form, Albert said.
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Also in 2013, Albert said the company is looking to take the tool global. "In China, South America, Africa … they don't have the infrastructure like we do here, " he said. Medical establishment is "the toughest" in the U.S., Albert said, and because the monitor has seen such success in the states, he hopes to expand it to countries that "don't have this existing technology," he said.
Remote monitoring devices have become hot commodities lately, with similar companies, such as Nuubo , offering a wireless platform for monitoring heart health. In fact, the company offers a portfolio of mobile technologies for cardiac prevention, diagnostics and rehabilitation solutions. Nuubo's nECG tool acts like the AliveCor app but uses three elements to gather heart health information: its BlendFix textile, which captures a patient's ECG; its nECG minder, which registers the patient's ECG signal captured by the textile; and then the nECG suite, which is Web-based software, similar to the AliveCor website, which allows for report generation diagnosis and HRV analysis.
In addition to AliveCor, a number of "life-saving" apps have been released as of late. According to an article in PC Mag, apps similar to AliveCor include Philips Vital Signs camera, an iOS app that can gather a patient's heart and respiratory rate without direct contact with the patient, and WiThings blood pressure monitor, which is used by physicians in conjunction with its iOS app to take and record blood pressure. The results can then be emailed, stored, tracked and even graphed.
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