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News Breaks
April 22, 2014
08:35 EDTISRGIntuitive Surgical announces FDA clearance of da Vinci Sp Surgical System
Intuitive Surgical announced it has received FDA 510(k) clearance for the da Vinci Sp Surgical System, which is designed to expand the company's single-incision product offering. This initial clearance is specific to urologic surgical procedures that are appropriate for a single port approach. The company does not intend to commercialize the da Vinci Sp technology until the current technology is engineered to be fully compatible with the newly released da Vinci Xi Surgical System, currently projected for the second half of 2015. This will require product refinements, supply chain optimization and additional regulatory clearances.
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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.
November 10, 2014
07:57 EDTISRGIntuitive Surgical survey positive on hernia opportunity, says JPMorgan
JPMorgan said its survey of 25 U.S.-based general surgeons who have used da Vinci for hernia procedures yielded positive outlook on the hernia opportunity for Intuitive Surgical. The firm says the complexity of the robot does not appear to be an issue. It keeps an Overweight rating on Intuitive with a $550 price target.

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