In this post, we are going to drill down into the second criterion and what it
means. The Second Criterion - Represent breakthrough technologies; No approved or cleared alternative exist;
Offer significant advantages over existing approved or cleared alternative...
Unfortunately, yesterday the CMS (Centers for Medicare and Medicaid Services) issued a public
notice delaying the effective date of the MCIT final rule for 60 days and opening a new 30-day comment
In this post, we are going to drill down into the first criterion and what it means. The First
Criterion: Provide for more effective treatment or diagnosis of life-threatening or irreversible
debilitating human disease or conditions.
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.
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