FDA

Multi-function mobile vitals monitor by Sotera Wireless receives FDA clearance

Digital Health Startups with iMedicalApps
Apr 17, 2012 by
mHealth News
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Sotera Wireless receives FDA 510k approval for its ViSi Mobile body area network technology.

Echo Therapeutics denied FDA approval for Prelude transdermal drug delivery platform, at least for now

Apr 05, 2012 by
mHealth News
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Echo Therapeutics Prelude Skin Prep System is referred to DHHS Combination Products Department, indefinitely delaying product launch in US.

Bringing “medical grade” security to hospital WiFi

Apr 03, 2012 by
mHealth
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I recently covered the announcement out of the West Wireless Health Institute that they were launching the West Wireless Health Council to pioneer the adoption of Medical Grade Wireless at hospitals and health systems across America. The Council is managed by an all-star team of CIOs from leading providers and by all indications they have been very well received by the health care community and are well on their way to achieving their goal of ubiquitous adoption. Recently, I had [Read more]

West Wireless Institute: aggressively advancing the mHealth ecosystem, interview CMO Joe Smith, MD

Mar 19, 2012 by
mHealth
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There is no single organization worthy of mention in the same breath with San Diego-based West Wireless Health Institute when discussing the contribution of non-profit groups to the mHealth movement. Founded by billionaire entrepreneurs Gary and Mary West, and guided by a blue chip laden executive team with all of the elements required to both think big and execute, the Institute has burst onto the scene in 2011. It seems as if each week the Institute launches a new initiative, [Read more]

The best of iMedicalApps, the first installment of March

Mar 16, 2012 by
Featured mHealth News
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March is here, and that means nicer weather along with March Madness! Because we know you have busy lives (along with a lot of basketball to watch) we have condensed for you our top, favorite posts of March thus far. For this installment, we discuss everything from the new iPad to ways you can take an idea for a healthcare app and turn it into a reality. We also look at ways social media is influencing various aspects of patient care.

What are the legal implications when adverse drug effects surface on social media ?

Mar 13, 2012 by
Commentary mHealth
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[We are pleased to present this guest article by Dr. McMenamin, who was a practicing emergency physician before turning his sights to the practice of law. He is currently a partner at McGuireWoods LLP specializing in health-related litigation.] By: Joseph McMenamin, MD, JD Before a pharmaceutical company may lawfully sell a new drug in the US, the FDA requires a showing of safety and efficacy. Assembling sufficient data is costly in dollars and time. Even then, relatively few humans are [Read more]

Advanced Brain Monitoring is pushing boundaries of mobile EEG, interview with CEO Chris Berka

Digital Health Startups with iMedicalApps
Feb 09, 2012 by
mHealth
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Interview with Chris Berka, CEO of Advanced Brain Monitoring in regards to their products and receiving small Business Innovation Research grants.

The patient’s dilemma: big companies won’t allow disruptive innovation in health care #mhs11

Dec 09, 2011 by
Featured mHealth
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During one of the mHealth Summit’s final “super sessions”, entitled The New Wireless Paradigm in the Medical Device Industry, Tom Watlington, CEO of San Diego-based startup Sotera Wireless, stuns a crowd full of mHealth enthusiasts when he calls out the big boys (Phillips, Medtronic, SAP) for intentionally stifling innovation directly to their faces. Bravo Mr Watlington.

Clinical decision making apps draw interest from FDA, iMedicalApps shares provider perspective with FDA

Sep 15, 2011 by
Featured mHealth
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The FDA turns its attention to clinical decision support medical apps and the discussion creates insights not only into the coming regulations but also the future of the industry.

The future of medicine hangs on the subtleties of “use”

Jul 27, 2011 by
Commentary Featured mHealth News

[Ed. This is the third of a three part series examining the past & present of FDA regulation of mHealth] The debate over the adoption of electronic health records and health IT systems by physicians has largely focused on the concept of “Meaningful Use”. It was this term chosen by the Dept of Health and Human Services Office of the National Coordinator (ONC), the sub-agency charged with distributing subsidies awarded in the Obama stimulus to physicians who adopt electronic medical [Read more]

FDA regulation of mHealth, part 2: FDA scope & culture

Jul 27, 2011 by
mHealth News
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In this article, we are going to delve a bit into FDA culture, the recent final ruling on “MDDS” devices and try to guess how the FDA will interact with future mHealth devices.

FDA Regulation of mHealth, Part 1: FDA basics

Jul 26, 2011 by
Featured mHealth
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As many of our readers know, the role of the FDA is evolving with respect to mobile medical software and devices. There is no question that the FDA has jurisdiction to regulate medical software, not to mention a responsibility. In this article, we will examine the basics of FDA regulation of medical devices.