Spotlight On... JAMA study finds popular app for measuring blood pressure is inaccurate ; Zimmer launches trio of hip products; ConforMIS launches iTotal PS hip replacement; and more...

A study in the Journal of the American Medical Association determined that a best-selling mobile health app to estimate blood pressure produced many false negatives, giving users the incorrect impression that the metric was in the normal range when in fact it was dangerously high. AuraLife's Instant Blood Pressure app was downloaded at least 950 times per day for $4.99 between June 2014 and July 2015 before it was taken off the market (though the app could still be on patients' phones). Rather than using a standard blood pressure cuff, patients were instructed to place the top edge of their smartphone on their chest and put their right index finger on top of the device's camera. Newport Beach, CA's AuraLife does not appear in the FDA's approval databases, even though the app clearly meets agency's definition of a mobile health app that should be regulated because it performs the function of a traditional medical device and could pose a risk to a patient's safety if it does not work as intended. AuraLife CEO Ryan Archdeacon said the study is invalid, and that the software has been updated to improve accuracy by 30%. Here's the study | More

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> ConforMIS ($CFMS) has launched its iTotal PS, a customized posterior stabilized knee replacement system that it said nearly triples its potential market. More

> Zimmer Biomet ($ZBH) has launched three new hip products: the Echo Bi-Metric Microplasty Stem, G7 Dual Mobility Construct and Arcos One-Piece Revision System. More

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Pharma News

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Pharma Manufacturing News

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Pharma Asia News

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> HK-based Chi-Med doses first patient in China PhII thyroid cancer trial of sulfatinib. More

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