Core Viewpoint - The company has received the Medical Device Registration Certificate from the National Medical Products Administration for its disposable intracardiac ultrasound imaging catheter, indicating a significant regulatory milestone for the product [1] Product Details - The product is designed for use in medical institutions in conjunction with portable digital color ultrasound diagnostic devices for ultrasound imaging of the heart, major blood vessels, and intracardiac anatomical structures [1] - When used with a three-dimensional cardiac electrophysiology mapping system, the catheter provides catheter positioning information, enhancing procedural accuracy [1] - The catheter features magnetic positioning capabilities, allowing for simultaneous ultrasound imaging and catheter localization, which provides additional intraoperative information to physicians [1]
微电生理:产品一次性使用心腔内超声成像导管获得注册证