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How a Blood Test Startup Successfully Defeated a US Top100 Company

Author: Edward O. Welles

The story of a biomedical start-up sued by an industry giant for theft of trade secrets, and how the start-up triumphed. 


Three bills affecting FDA medical device oversight advance in US senate

Author: By Stewart Eisenhart, Emergo Group
Proposed legislation targeting the Food and Drug Administration’s medical device premarket review processes as well as the scope of the agency’s oversight over medical software are now closer to approval in the US Senate.Three bills passed by the Senate Health, Education, Labor and Pensions Committee would specifically allow more types of devices to qualify for expedited US market access; utilize medical device premarket review processes more so than those for pharmaceuticals to review combination products; and limit or preclude FDA regulation of certain types of medical software.

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Pacifiers: Are they good for your baby?

Author: By Mayo Clinic Staff
The decision to use a pacifier — or not — is up to you. Consider the do's and don'ts of giving your baby a pacifier, and how to help him or her break the habit.

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Venture firms pump $4.6 billion into healthcare information technology in 2015, Mercom says

Author:Bernie Monegain Editor of HIMSS Media
Since 2010, the sector has received $13.4 billion in VC funding in 2,050 deals and almost $7 billion in debt and public market financing.

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What Theranos and 23andMe teach us

Author: January 7, 2016 By Florence Comite, MD Founder and CEO,ComiteMD
Whether it’s Uber transforming the taxi and limousine business or Airbnb shaking up hospitality, we have become used to upstarts disrupting traditional industries.So, when Theranos pledged to overhaul phlebotomy a few years ago, few doubted that it would become a Silicon Valley darling...

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Why Medtech Firms Need to Focus on Asia-Pacifc

Author: W. Gregory Shearer Leading Healthcare Investment Banker I Private Placements I M & A   Jan 7, 2016
The medtech markets in Asia-Pacific have proved to be a hard nut to crack, but it would be premature to give up now.A new research report from McKinsey & Company contends that the industry should redouble its efforts arguing that so far "medtech companies have approached Asia-Pacific's diverse and volatile markets cautiously" but "the region's underserved patients deserve a greater commitment." 

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A Biotech New Year’s Resolution

Author:Ron Renaud, CEO of RaNA Therapeutics
It is that time of the year again when we start to get ready for the New Year. It is also the time of the year that involves an inordinate amount of hectic activity with board meetings, regulatory deadlines, presentation preparation for JP Morgan, and general holiday stress. Even with the craziness, there is usually an excitement because we know there is a brief lull with the holidays that allow us to catch our collective breath before we descend on San Francisco to get on the biotech roller coaster ride of the New Year.
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Commentary: Using open innovation and cognitive computing to solve healthcare's vexing problems

 Author: Nicole Gardner, vice president and U.S. federal healthcare industry leader for IBM Global Business Services.
The growth of data in healthcare is occurring at a faster pace than in any other industry. Over the next two years, the projected volume will nearly double, with 88% of it unstructured. The data are coming from electronic health records, test results, patient sensors such as wearables, bedside medical devices and implants.

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Gene Editing Trials Poised to Expand, but Hurdles Remain

 Author:Ricki Lewis, PhD, Adjunct Professor of Medical Education, Author of McGraw-Hill Higher Education
Gene editing has already garnered headlines, financial buzz, and even a few preliminary clinical successes. Thus far, however, few formal clinical trials are in progress, but improvements in the technology are expected to accelerate the pace of clinical development as early as 2016. In advance of that projected expansion, experts are gathering this week in Washington, DC, to address the technical and ethical considerations raised by the technique, which has the potential to alter a patient's germline DNA or the genes of an early embryo.

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Cell Therapy Goes Public

Author:Barbara Nelsen, PhD, MBA, The Founder of Nelsen Biomedical
We are currently experiencing a biotech “boom,” with biotech investing recently reaching an all-time high . 2015’s numbers are positioned to easily surpass 2014’s total of $6 billion in venture capital dollars raised. This favorable funding climate has been fueled in part by venture capital firms’ increased willingness to invest in risky, early-stage ventures. This shift has likely been influenced by the plethora of high-value biotech IPOs that have occurred over the past few years.

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Studies link air pollution as risk factor for anxiety and trigger for stroke

Author: Markus MacGill
Research into new questions about links between mental health and air quality has found an association between levels of anxiety and levels of fine particulate air pollution. A second paper in the same issue of The BMJ answers more established questions about links with stroke, too.

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