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News Breaks
June 25, 2014
08:40 EDTISRGIntuitive Surgical receives CE Mark for da Vinci Xi Surgical System
Intuitive Surgical announced it has received a CE Mark for its da Vinci Xi Surgical System. Achieving this milestone allows the company to market the Xi System in Europe and other countries that require the CE Mark. With the U.S. and European introductions underway, Intuitive Surgical is seeking additional regulatory clearances to market the da Vinci Xi System around the world. These include clearances for advanced technologies such as vessel sealing, stapling and fluorescence imaging, which are designed to enhance the capabilities of the da Vinci Xi System. This month, Intuitive Surgical received the first of these clearances from the FDA to market the EndoWrist One Vessel Sealer instrument for the da Vinci Xi System in the U.S.
News For ISRG From The Last 14 Days
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November 26, 2014
07:52 EDTISRGIntuitive Surgical could be hurt by FDA statement, says RBC Capital
After the FDA acknowledged that hysteroscopic morcellators do not pose the same degree of risk as laparoscopic powered morcellators, RBC Capital estimates that 6%-8% of Intuitive Surgical's total procedures would be exposed to a potential decline in laparoscopic powered morcellators in a worst-case scenario. However, the firm says the actual risk would be much lower for the company, as alternative robotic techniques can be used in some cases.
November 24, 2014
09:26 EDTISRGFDA updates warning on laparoscopic power morcellators to treat uterine fibroids
The FDA announced it is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April, the FDA warns against using laparoscopic power morcellators in the removal of the uterus or fibroids in the vast majority of women. In an Immediately in Effect guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications. Johnson & Johnson (JNJ), the largest manufacturer of morcellators, stopped selling the gynecological surgical tool in April and in August told customers to return any devices in their inventory. Intuitive Surgical's (ISRG) da Vinci surgical system can be used with tissue morcellators in such surgical procedures.

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