Robotic Hysterectomy: Procedures Increasing, But Questions Remain
Controversy continues to swirl around robotic surgical procedures and this time the target is robotic hysterectomy. However, the drama does not seem to be impacting the number of these procedures performed robotically, a statistic that is clearly on the rise.
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The agency is set to hold a workshop on Robotically-Assisted Surgical Devices later this month. In advance, FDA issued a discussion document exploring questions and concerns over how to regulate these devices in the future.
Robotic-controlled surgical tools – led by market leader MAKO Surgical Inc. – are beginning to take root in the knee surgery market, at least in partial knees. Perhaps the truest measure of the potential of this market is the growing competition that MAKO is facing: just over the past five months, Blue Belt Technologies and Stanmore Implants Worldwide received FDA approval for rival robotic surgical systems.
An apparent increase in adverse event reports with Intuitive Surgical’s popular robotic surgery system has triggered further inquiry from FDA.