iDrive Surgical Devices Receive FDA Clearance
Power Medical Interventions Inc. said the FDA cleared its intelligent iDrive surgical devices, which includes a suite of reusable, self-contained, hand-held devices that can be used to power and control PMI's existing suite of Digital Loading Units. The Digital Loading Units include a linear cutter, right-angle linear cutter and circular staplers. The company's first generation of technology, the SurgASSIST, required the use of an external power console, flexible drive shaft and separate remote control unit. The company says these functions can now be performed by a single hand-held iDrive unit. The iDrive has been cleared for a broad range of applications in open and endoscopic surgery.
PMIï¿½s Intelligent Surgical Instruments are computer-assisted, power-actuated endomechanical instruments that surgeons use for cutting, stapling and tissue manipulation.