April 11, 2016
AliveCor is continuing to build up the clinical evidence for the efficacy of its smartphone-connected Kardia ECG devices. According to a new posting on ClinicalTrials.gov, AliveCor is gearing up to launch a 300-patient randomized trial at Columbia University to test the effect of technology-enabled remote monitoring on atrial fibrillation.
"Atrial fibrillation (AF), a condition where the top...
March 26, 2013
It's possible that folks in the industry can be a little too quick to call out signs of the times that mobile health has "gone mainstream" or "hit the big leagues." But there certainly have been some strong signs lately. Samsung announced mobile health features as a key part of its release strategy for the Galaxy S4. The House of Representatives hosted three days to holding hearings on mobile...
March 12, 2013
Cardiac Designs' FDA-cleared ECG Check, not yet commercially available.
A new ECG device for the iPhone 4s called ECG Check received over-the-counter clearance from the FDA last month. The device, which would be the first product from Park City, Utah-based Cardiac Designs, appears very similar to the AliveCor Heart Monitor, which is currently only cleared for prescription use. The device was...
February 18, 2013
If there's one device that's recently become a symbol for the promise -- and potential pitfalls -- of mobile health, it's AliveCor Heart Monitor, formerly known as the AliveCor iPhone ECG, which received FDA clearance for prescription use in December. Dr. Dave Albert, AliveCor's chief medical officer, outlined some next moves for the company recently in response to an online conversation about...
October 19, 2012
After leading the Scripps Translational Science Institute to a $3.75 million Qualcomm Foundation research grant, Dr. Eric Topol has cut ties with the West Health Institute, an organization he co-founded and served as vice chairman of.
Topol confirmed to MobiHealthNews that he left West at the end of September after his three-year term on the board expired. But he also said that the institute's...
February 27, 2012
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...
October 26, 2011
Researchers at the Swiss university Ecole Polytechnique Federale de Lausanne (EPFL)'s Embedded Systems and Telecommunications Circuits lab have developed a non-invasive wireless cardiac monitor powered by a smartphone. The prototype is intended to alert potential patients and their doctors to cardiac anomalies.
The wireless body sensor network (WBSN) uses four sensors applied to the skin, as...
March 23, 2011
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...