By Adam Golodner and Ali Wright Partner Adam Golodner discusses the importance of actionable cybersecurity plans. In an age where the critical infrastructure of almost every government, organization, and network depend on technology, cyber issues have quickly risen to the forefront of the discussion surrounding security. In fact, the United States has declared cyber as […]
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BSX loses $100m pelvic mesh case | Medtech legal news for the week of June 1, 2015
Report: Boston Scientific loses $100m pelvic mesh case May 28, 2015 by Brad Perriello A Delaware state jury issued a $100 million judgment against Boston Scientific in a personal injury lawsuit filed over its Pinnacle and Advantage Fit pelvic mesh products, Bloomberg reported. The jury found that the devices, used to treat pelvic organ prolapse […]
Creating a compliant, lock-tight site budget for clinical trials
By Kathi Shah, MS, MBA
Creating a clinical trial site budget sounds simple right? A Sponsor contracts with an investigative site to conduct a clinical trial per the protocol. The Investigative site is compensated by the Sponsor to conduct the services outlined in the protocol. The relationship between the Sponsor and Investigative site is heavily weighted on the budget developed to compensate sites for their efforts to conduct the study.
Interoperability and the trough of disillusionment
The ABIM, its finances, and the great collusion
Sunlamp products & UV Lamps: 3 months to submit 510(k)s to FDA
By David Lennarz, Vice President and Co-Founder of Registrar Corp
21st century cures act
FDA gives public access to Global Unique Device Identification Database (GUDID)
By Angela Brown
Maintenance of certification controversy dominates day one of the 2015 Heart Rhythm Society Scientific Sessions
Fighting crime in the health enterprise: Five tips for building academic-industry partnerships
By Lisa Fratt
Bruce Zetter, PhD, wears quite a few hats: Pioneer. Partner. Teacher. Mentor. Charles Nowiszewski Professor of Cancer Biology in Boston Children’s Hospital’s Department of Surgery.
Today in JAMA: ABIM MOC program’s evidence base gets destroyed
Paul Tierstein, MD and Eric Topol, MD critically review the evidence base for the American Board of Internal Medicine’s Maintenance of Certification program in the Journal of the American Medical Association (JAMA) and the results aren’t pretty: