冷冻探头
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康沣生物-B:冷冻粘连治疗系统的一次性使用冷冻探头变更注册获得国家药监局批文
Zhi Tong Cai Jing· 2025-08-07 12:29
Core Viewpoint - 康沣生物-B (06922) has received regulatory approvals for its cryoadhesion treatment system and its disposable cryoprobes, enhancing its commercialization pathway for respiratory intervention products [1] Group 1: Regulatory Approvals - The disposable cryoprobes received approval from the National Medical Products Administration (NMPA) on January 9, 2024 [1] - The registration change for the cryoprobes was granted by the NMPA on August 5, 2025 [1] Group 2: Product Features and Applications - The cryoadhesion treatment system utilizes subcritical cooling technology and controlled pressure heat transfer technology for rapid freezing adhesion [1] - The system is designed for the removal of foreign bodies, mucus, blood clots, and necrotic tissue in the airway, as well as for cryobiopsy of bronchial and lung tissues [1]
康沣生物-B(06922):冷冻粘连治疗系统的一次性使用冷冻探头变更注册获得国家药监局批文
智通财经网· 2025-08-07 12:26
Group 1 - The company 康沣生物-B (06922) has received regulatory approval from the National Medical Products Administration (NMPA) for its disposable cryoprobes on January 9, 2024, enhancing its commercial pathway for the cryoadhesion treatment system [1] - The registration change for the disposable cryoprobes to cryoprobes was approved by the NMPA on August 5, 2025, indicating a significant step in product development [1] - The cryoadhesion treatment system utilizes subcritical refrigeration technology and controlled pressure heat transfer technology for rapid freezing adhesion, aimed at removing foreign bodies, mucus, blood clots, and necrotic tissue in the airway, as well as for cryobiopsy of bronchial and lung tissues [1]