Illustration of a rocket bursting through a wall

The Breakthrough Device Program: Part 1

Welcome to our blog, where we will try to clarify the obtuse announcements from FDA and CMS and cover other topics to biomedical firms. We hope you are able to take away some pearls in each of our posts. We will start with the recent FDA final guidance on Breakthrough Device Program. This will be three segments, which will segue into reimbursement and clinical trial impacts.

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TAMM Net logo and Vulcan-V logo


On March 18, the Department of Defense (DoD), Defense Health Agency (DHA) responded to the global health crisis associated with increasing demand for ventilators with a challenge to develop low cost ventilators. This innovation challenge was launched on the Vulcan platform. Over the course of 7 days, 172 innovative ideas, two different panels of engineering and medical experts, selected 5 of the most promising designs; hence VULCAN V emerged!

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