US Medical Innovations announced today that it won FDA 510(k) clearance for its Canady Plasma Smart XL-1000 electrosurgical generator with accessories for producing plasma gas.
The CPSXEG is designed to combine high-frequency voltage to electrically enhanced plasma gas to produce a plasma gas stream, with modes including Canady hybrid plasma, argon plasma and standard cutting and coagulation modes.
US Medical Innovations said the CPSXEG is the first smart electrosurgical generator in the world with its own operating system, the Graphical Integrated Management Surgical System (GIMMS), which includes pre-loaded apps, data collection, built-in safety features and the integration of other surgical devices, according to a news release.
With the CPSXEG, the user can choose specific surgical applications by touching a particular app screen on the device’s smart pad touch screen monitor. The device is also capable of downloading secure procedural data into the electronic medical record of the patient.
US Medical Innovations said the CPSXEG will be manufactured at Canady Biotechnology in Takoma Park, Md., and scheduled for shipment in the U.S. and Middle East in December 2019.
“The Canady Plasma® SMART XL-1000 electrosurgical generator with accessories is the next generation of electrosurgical generators,” US Medical Innovations chief science officer Dr. Jerome Canady said in the release. “USMI is the first to transform an electrosurgical generator from analog to smart technology. The new generator is integrated with USMI’s patented Canady Hybrid Plasma (CHP) technology that is used to simultaneously cut, coagulate, and ablate biological tissue during surgery.”
