Newsroom

Share the news with our latest stories and featured posts that highlight what’s going on at Intuitive today. For recent public affairs statements, see Notifications. Members of the media can contact us at corpcomm@intusurg.com or visit Press Resources.

 

 

 

 

 

 

 

 

 

 

 

 

 

Frequently Asked Questions

Notifications



February 2024
Response to recent media coverage



October 2023
Response to New York Times coverage



August 2021
Statement on FDA Safety Communication from Aug. 20, 2021

Intuitive’s primary focus is patient safety. We recognize and support FDA’s important role in protecting and promoting public health, including its oversight of clinical trials.

Intuitive follows FDA regulation and guidance, and Intuitive’s ongoing U.S. clinical investigation on the safety and effectiveness of robotic-assisted surgery in prophylactic nipple-sparing mastectomy has been approved by the FDA under an Investigational Device Exemption.

The Safety Communication issued on August 20, 2021 by the FDA, is specific to the use and study of robotic-assisted surgery in mastectomy. It affirms that “RAS devices have been cleared for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy and colectomy. These clearances are based on short term (30 day) patient follow up.”

The FDA has not evaluated robotic-assisted surgical devices for the prevention and treatment of cancer based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.

Intuitive believes that any treatment or medical intervention should be informed by discussions between surgeons, clinicians and patients that consider all options, the associated risks and benefits, the surgeon’s or clinician’s own training, experience and outcomes.



July 2021
Regarding recent media coverage

We want to correct a misleading assertion made in recent media reports about da Vinci surgical systems. Intuitive does not have the ability to remotely shut down a da Vinci surgical system during a procedure underway at a hospital.

For patient safety purposes, there are circumstances in which a da Vinci surgical system may automatically stop functioning if operated in an unsafe manner or if a serious error is detected. Further, we maintain robust cybersecurity controls that prevent access to the systems that could modify their behavior during surgery.

Intuitive values the safety and well-being of surgeons and their patients. “Patients first” is core to our mission and foundational to what we do, and why we do it.