Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue a discussion that will span several parts. The conversation is centered around the recently released Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. We highlight a good number of points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this part include:Alleged recommendation by FDA for the da Vinci Surgical System to be submitted as a 510(k) rather than as a PMA as originally submitted by Intuitive Surgical.Clinical trials for drugs compared to those for medical devicesFootage of the Essure review meeting and comments made during the meetingThe MAUDE event reporting systemBefore listening to the podcast, it would be best to view the documentary via Netflix. Listen to the podcast streaming via the player or get the p