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This email from group member Bill Vick deserves your attention and pass-along through email, LinkedIn, Facebook, and Twitter. He writes, "In September 2011 after months of tests, my physician gave me the news, “Bill, you have Idiopathic Pulmonary Fib...

For 10 years, Dexcom made this claim: Continuous glucose monitoring (CGM) is intended to supplement, not replace, a blood glucose meter. A confirmatory finger stick is required prior to treatment. This is known as an adjunctive claim, because the mon...

The US Government Accountability Office (GAO) published a report, "CMS Should Evaluate Providing Coverage for Disposable Medical Devices That Could Substitute for Durable Medical Equipment" at http://medgroup.biz/CMS-disp GAO identified eight potenti...

Richard A Baron, Dave Sheppard, Teresa Gonzalo, and Enzo Villani led our panel at the 10x Medical Device Conference and you can access the full recording at http://medgroup.biz/funds Among the topics they discussed: What kind of capital should I rais...

Did you know there were more than 2.5 million medical device adverse events reported in the last three years alone? There’s a daunting amount of data out there about medical device quality and safety and my friends at Reed Tech will help you find and...

If you were asked to name a price at which you'd sell your company, could you do it? What can you do today to achieve the greatest enterprise value, even if you have no immediate plans to sell? Dave Sheppard (formerly VP, Covidien) and Florence Joffr...

My presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDRNew legal obligations and...