Intuitive Surgical (NSDQ:ISRG) won FDA clearance for its EndoWrist vessel sealer designed for use with the company’s da Vinci surgical robot.
The Sunnyvale, Calif.-based med-tech maker’s device is wristed to give clinicians full control over vessel sealing in vessels up to 7mm.
The company plans to initiate a controlled rollout of the EndoWrist system during Q1 of 2012 while simultaneously submitting for a CE Mark, according to a press release.
The sure-handed robots, which garnered a lot of buzz on the web when hospital workers uploaded videos of the da Vinci peeling grapes, building paper airplanes and "dancing" on the popular video-sharing site YouTube.
The robot has been a huge boon for Intuitive Surgical and may have applications that take it beyond our planet, according to NASA.
NASA scientists and researchers at Johns Hopkins University are looking at the medical machine to see if it may could one day help repair or refuel satellites in orbit.
Sending robots to space is far less costly and dangerous than sending a human to repair the satellites, and human operators would still be in control of the remotely operated da Vinci system.
News of the regulatory win sent ISRG shares to a new 52-week high of $474.50 yesterday.
NinePoint lands 510(k) clearance for Nvision
NinePoint Medical Inc. landed 510(k) clearance by the FDA for its Nvision VLE imaging system. The Cambridge, Mass.-based company plans to start clinical trials this year and is pushing for a production launch in 2013. Read more
Soft tissue repair approved in Europe
Freemont, Calif.-based Biomerix Corp. won CE mark approval for its Assure soft tissue repair mesh. The company’s synthetic tissue scaffold is used for the reconstruction of hernias and soft tissue deficiencies. Read more
Elron subsidiary wins CE Mark
Elron Electronics Industries subsidiary Pocared Diagnostics landed CE mark approval for its in-vitro diagnostic medical devices. Pocared began clinical trials in Nov. 2011 for approval in the U.S. Read more