In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the government shutdown and its potential impact on medical device manufacturers and their submissions. This shutdown is almost one month in, and its conclusion does not seem to be in the near future. So, what do you do if you have a device being submitted to the FDA, already under review, or some other scenario involving the agency? During this conversation, the follow...
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the government shutdown and its potential impact on medical device manufacturers and their submissions. This shutdown is almost one month in, and its conclusion does not seem to be in the near future. So, what do you do if you have a device being submitted to the FDA, already under review, or some other scenario involving the agency? During this conversation, the follow...
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re revisiting real-world evidence (RWE), which is a topic that’s been getting some attention. So today, we’re going to look at what’s driving that attention and discuss the reasons behind it. We’ll also talk about how the FDA is seeking to use real-world evidence. Specifically, the following questions are addressed: We’ve discussed real-world evidence previously, in podcasts from 2...
Medtech Matters
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the government shutdown and its potential impact on medical device manufacturers and their submissions. This shutdown is almost one month in, and its conclusion does not seem to be in the near future. So, what do you do if you have a device being submitted to the FDA, already under review, or some other scenario involving the agency? During this conversation, the follow...
