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Insights & Analysis

There’s one constant in healthcare: change. Count on us to break down the trends so you can stay up to date. Follow our take on each piece of this deep, intertwined, and often perplexing industry to find opportunities and practical approaches to move healthcare forward.

FDA Releases Final Guidance on Pre-Submission Program for Medical Devices

On Feb. 18, FDA released guidance outlining how an applicant can obtain FDA feedback on a potential or planned medical device submission reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), including the Pre-Submission (formerly pre-Investigational Device Exemption (pre-IDE)) program.

Report Finds More Than $1.3 Billion in Potential Savings Through Diabetes Prevention Legislation

An Avalere Health study commissioned by the American Diabetes Association, YMCA of the USA (YMCA), in collaboration with the American Medical Association (AMA) focusing on HR 962/S 452, The Medicare Diabetes Prevention Act (MDPA), found that if enacted, the bill would save the Federal Government $1.3 billion over 10 years, and would also dramatically reduce diabetes among Medicare beneficiaries.

Big Data Continues to Shape Healthcare in 2014

There is a rapid expansion of large and diverse data sets -- what is more commonly referred to as Big Data - as a result of the digitization of clinical and research data.

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