Life Science Compliance Update

May

2018

The Intersection Between Patients, Health Information And Devices – New FDA Guidance Attempts To Prevent A Traffic Accident

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Gwendolyn Ball, Staff Writer, Life Science Compliance Update

The rapid of expansion of connected medical devices producing patient-specific health information is the focus of a new FDA guidance document. This article explores the requirements in the guidance and what impact it might have on medical device manufacturers.


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April

2018

It’s Not All About the Money – Medtronic’s Infusion Multi-State Settlement Agreement

Written by , Posted in Uncategorized

Robert N. Wilkey, Esq.

In a closely watched matter culminating years of litigation, Medtronic in December 2017, entered into a $12 Million multi-state settlement resolving allegations that the medical device company had misled consumers about the safety, efficacy, and effectiveness of its Infuse® Bone Graft Device (“Infuse”). The settlement represents continued coordination among States to prosecute marketing fraud and false advertising within the medical device industry.


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