In this week’s podcast, we’ll visit with John McCutcheon, president and CEO of EBR Systems, which is developing a miniature pacemaker that is powered by ultrasound and located in the left ventricle of the heart. McCutcheon shares his plans for the start-up but more on the point of this week he recalls his experience as CEO of Emphasys Medical, an interventional pulmonology start-up that received a shocking negative recommendation from an FDA panel in 2008. The no vote led to the shutdown and sale of Emphasys, but the rejection ultimately helped convince the FDA and industry to assess their relationship. Ultimately, the two sides improved relations as McCutcheon explains in the podcast. The rejection is somewhat reminiscent of the negative vote issued this week by an advisory panel for Medtronic’s Symplicity Spyral renal denervation (RDN) therapy for hypertension. McCutcheon explains how the negative impact impacted him at the time, but more important how he’s moved on to appreciate the experience.
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