苏州市助力医疗器械产业创新活力持续迸发 累计65款产品进入审批快车道

Group 1 - Recently, two medical devices from Suzhou have entered the national special approval channel for innovative medical devices, allowing for prioritized review and faster clinical application [1] - Suzhou has a total of 65 innovative medical devices in this fast-track approval process, accounting for 10% of the national total and 60% of Jiangsu province [1][2] - The National Medical Products Administration (NMPA) has announced that 14 innovative medical devices have been approved for special review, including a near-distance radiation therapy planning software and a catheter-based radiofrequency ablation system [1] Group 2 - The near-distance radiation therapy planning software is designed to dynamically guide equipment for improved treatment outcomes [1] - The catheter-based radiofrequency ablation system aims to address the treatment challenges of hypertrophic obstructive cardiomyopathy and has received breakthrough device designation from the FDA [1] - The special review process for innovative medical devices is intended to accelerate the domestic replacement of high-end medical devices and break the import monopoly [1][2]