With the announcement that Medtronic is going back to the clinical drawing board after the pivotal SYMPLICITY HTN-3 trial of its renal denervation device failed to meet its primary efficacy endpoint, the industry is taking a cautious but still optimistic stance on the highly touted potential treatment for resistant hypertension.

A decade ago, incuabators were seen as the best medicine for what then ailed the medical device industry, most notably a complex regulatory pathway and a difficult venture financing climate. Perhaps not surprisingly, as both the regulatory path and venture financing grew easier in the mid 2000s, incubators began to struggle, victims of their own financing problems. More recently, two huge acquisitions, Abbott's purchase of Evalve and Medtronic's of Ardian, suggest that at least one incubator, The Foundry, is proving that incubation works.

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.