Intuitive Surgical (ISRG) Expert Call Takeaways - Oppenheimer
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Oppenheimer analyst Suraj Kalia reiterated an Underperform rating and $410.00 price target on Intuitive Surgical (NASDAQ: ISRG) after holding an expert call with a regulatory expert in the robotic surgery space to discuss shifts in regulatory pathways for new robotic surgery platforms. Key takeaways include:
1) Starting 2016/17, FDA got concerned about potential for injury given reported issues with daVinci, both from a device perspective and poor surgeon training
2) Verb Surgical was surprised at the FDA's pushback against a traditional 510k, which has led to a reshuffle in its approach
3) FDA's judgement is somewhat colored with what it has learned on the daVinci
4) De Novo pathway likely approach now for new platforms, with special controls for each depending on uniqueness of that platform
The analyst stated "In our view: 1) Unclear if the FDA carrying risk mitigation on newer platforms due to safety concerns with daVinci is the right approach or not; 2) For ISRG, the delay in newer platforms coming online buys some time; 3) However, if newer platforms are able to mitigate risk appropriately, that could help
competitively define them."
Shares of Intuitive Surgical closed at $713.37 yesterday.
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