The FDA has granted a 510(K) Class II clearance to San Francisco-based AliveCor's iPhone-enabled heart monitor, which has been commonly known as the "iPhoneECG" since it first made an appearance at CES two years ago. The company announced the clearance as the mHealth Summit kicks off this week in the Washington DC area. AliveCor will begin pre-selling the $199 clinical-quality, ECG monitor,...
AliveCor's iPhoneECG device, which was the talk of CES in 2011, is close to securing a CE Mark, paving the way for the device to roll out commercially in Europe. At least one speaker at the HIMSS event last week and at least one report coming out of the Burrill Digital Health Meeting earlier this month, claimed that the iPhone ECG's CE Mark was already secured. AliveCor founder Dr. David Albert...
AliveCor, developer of the iPhone ECG, announced this week that it has raised $3 million in its first round of funding. The investment was funded by Burrill & Company, Qualcomm Ventures and the Oklahoma Life Sciences Fund.
The company plans to use the investment to expand its team, gain regulatory approval and market the device worldwide. AliveCor expects to commercially launch its iPhone...
A week ago, MobiHealthNews shot down the myth that the U.S. Food and Drug Administration (FDA) plans to start regulating mobile medical apps. In reality, the FDA has been regulating mobile software for years.
Way back in 1997, Data Critical, a company bought by GE Healthcare in 2001, earned FDA 510(k) clearance for its RhythmStat XL software that wirelessly transmits ECG data from a heart monitor...
AliveCor's iPhone ECG is not an FDA-approved medical device
Dr. David Albert is one of wireless medicine's old guards. As he puts it: "I did what AirStrip is doing 15 years ago with the first Nokia smartphone. I also have a patent that is probably the seminal patent for handheld ECGs, but GE owns that now since they acquired my company. I'm an old pro in this business."
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