Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at guidances published by FDA regarding the 510k regulatory pathway. The sub…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at the recent rise in recalls that are being tied back to manufacturing issu…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at a guidance from the FDA that explains how product sponsors can submit a p…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA policy regarding the use of a recalled device as a predicate in a 510k s…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the 483s and warning letters that resulted from FDA inspections in 2022. The lis…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue to discuss lab developed tests (LDTs) and whether or not the FDA should have th…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the debate over lab developed tests (LDTs) and whether or not the FDA should hav…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at what happens to products on the market under the FDA’s emergency use authorizati…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s use of the word “exempt” and what it means for medical device manufact…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at how a company can promote the off-label use of a medical device. It would seem t…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s Intended Use rule and how it impacts device labeling. It is also revea…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the Special Controls that are part of the FDA’s regulatory requirements for Clas…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s policy known as Refuse to Accept (RTA) as it relates to 510k submissio…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine medical device recalls. More specifically, the focus of the discussion is on vol…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a deep dive on the letter to file tool that companies can use for certain situation…

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Juliana Blum, Co-founder and Executive Vice Presiden…

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Andy Doraiswamy, founder and CEO of Koya Medical. He hig…

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Mike Favet, CEO of NeuroPace. He offers insights into ho…

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Elad Walach, Co-Founder and CEO of Aidoc. He explains ho…

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we highlight a number of areas in which the agency’s regulatory oversight could be consider…