FDA 510(k) Clears US Medical Innovations’ Canady Plasma Smart XL-1000 Generator

US Medical Innovations LLC (USMI), a Biomedical and Life Science subsidiary of US Patent Innovations, LLC (USPI) has received U.S. Food And Drug Administration (FDA) 510(k) clearance to market and sell the Canady Plasma Smart XL-1000 Electrosurgical Generator (CPSXEG) with accessories. The CPSXEG combines with a high frequency voltage to electrically enhanced plasma gas (i.e. Argon) to produce a plasma gas stream. The unit provides various plasma modes including Canady Hybrid Plasma, Argon Plasma as well as standard cutting and coagulation modes.
 
The Canady Plasma SMART XL-1000 Electrosurgical Generator is the first SMART electrosurgical generator in the world with its own operating system, the GRAPHICAL INTEGRATED MAGEMENT SURGICAL SYSTEM (GIMSS). GIMMS was developed by USMI’s engineering team in the United States. The GIMMS Smart Operating System includes pre-loaded Surgical Apps, data collection, built-in safety features and the integration of other surgical devices in the operating room. The CPSXEG has 12.1-inch diagonal Smart Pad color monitor touch screen, keypad, quick start application, tutorial screen, pre-surgical power settings for 400 physicians and user manual. The user can decide on the specific surgical application by touching the particular APP screen (i.e. General Surgery, Robotics, Orthopedics, Endoscopy, Gynecology, Transplantation, Plastic and Cosmetic Surgery, Trauma, Cardiology, Urology, Surgical Oncology, Pediatrics). Once the device is activated, name of physician, device recognition and safety features, power in watts, gas flow rate, gas volume, and energy mode are displayed on the monitor. The CPSXEG also has the capability to download secure procedural data into the electronic medical record of the patient.
 
The Canady Plasma SMART XL-1000 Electrosurgical Generator was developed by Jerome Canady, M.D. chief science officer and Taisen Zhuang, Ph.D., vice president of Research & Development and the engineering team at USMI (Takoma Park, Md.). The CPSXEG generator will be manufactured at Canady Biotechnology (Takoma, Park, Md.), a subsidiary of USPI scheduled for shipment in the United States and Middle East.
 
Dr. Canady, CEO of USMI and chairman of USPI’s family of companies, commented, “The Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories is the next generation of Electrosurgical Generators. 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. Unlike traditional plasma coagulation and standard electrosurgical devices, CHP technology creates a plasma gas energy beam that cuts and coagulates to a minimal invasive depth as low as 0.1 mm while maintaining a tissue temperature of approximately 98 degrees Fahrenheit (37 degrees Celsius) or less. The beam can coagulate blood vessels up to 4mm. CPSXEG via GIMSS can provide a simple solution to a complex Operating Room (OR) when integrated with the Canady SMART OR Stealth Integration System including surgical devices for a variety of surgical applications (i.e. robotic, advanced endoscopic, mini-invasive, complex surgical procedures, cosmetics, plastic reconstruction, burns, and trauma).”
 
US Medical Innovations LLC (USMI), based out of Takoma Park, Md., is a privately held FDA-registered life science and biomedical device company. USMI is dedicated to expanding the boundaries of plasma medicine by pioneering new technologies for the development of state-of-the-art medical devices that advance patient outcomes and improve human lives.