Intuitive Surgical (NSDQ:ISRG) won 510(k) clearance from the FDA for its da Vinci surgical robot to be used in laparoscopic cholecystectomy – or gall bladder surgery.
The clearance for Sunnyvale, Calif.-based Intuitive covers single-site instrumentation for the da Vinci Si model, which will allow surgeons with the device to perform single-incision cholecystectomies, according to a press release.
“We plan to immediately initiate a controlled roll-out of these products in the US, while continuing our roll-out in Europe,” CEO Gary Guthart said in prepared remarks. “As we learn more about our customers’ needs within single-incision surgery, we anticipate future submissions to the US FDA and other global regulatory agencies related to expansion of the cleared indications for use, as well as additional Single-Site instruments.”
EnteroMedics Inc. (NSDQ:ETRM) won approval from the Australian Therapeutic Goods Administration for “the critical active implantable medical device components” of its Maestro weight loss implant. Read more