滨松S360数字病理切片扫描仪荣获FDA认证,这是世界卫生组织认定的最高安全规范,标志着滨松S360数字病理切片扫描仪满足FDA法规及技术要求,正式走向临床诊断应用。
FDA 510(K)(Food and Drug Administration)认证,是美国食品药物管理局(U.S. Food and Drug Administration)的英文缩写,它是国际医疗审核权威机构,由美国国会即联邦政府授权,专门从事食品与药品管理的最高执法机关。根据风险等级的不同,FDA将医疗器械分为三类(Ⅰ,Ⅱ,Ⅲ),Ⅲ类风险,等级高;少量I、III类,多数II类的医疗器械,在美国销售,需要做“产品上市登记”(PMN : Premarket Notification)的认证。做 “产品上市登记” 所需提交的文件需满足美国法规 FD&C Act第510章节,故通常称做 “产品上市登记” 这类的认证为510(K)认证。
通过FDA认证的食品、药品、化妆品和医疗器具对人体是确保安全而有效的。在美国等近百个国家,只有通过了FDA认可的材料、器械和技术才能进行商业化临床应用。由于其科学性和严谨性,这一认证已成为世界公认的标准。
「病理乃医学之本」,病理学诊断被称作是疾病的金标准。滨松在数字病理领域已经深耕十余年,那台2006年首次在国内投入使用的NanoZoomer数字病理切片扫描仪,仍在北京协和医院持续稳定地持续工作着。
现如今滨松数字病理切片扫描仪的产品家族不断发展壮大,以NanoZoomer S360为代表的滨松病理切片扫描仪,以其高可靠性、高通量和高图像质量在国内外的病理图像人工智能领域得以广泛应用。
现如今滨松数字病理切片扫描仪的产品家族不断发展壮大,以NanoZoomer S360为代表的滨松病理切片扫描仪,以其高可靠性、高通量和高图像质量在国内外的病理图像人工智能领域得以广泛应用。
扫描通量
360张标准切片
高分辨率的成像系统
0.46µm/pixel20x 模式
0.23µm/pixel40x 模式
全自动机械运动系统
全球顶级扫描速度
30秒, 15x15mm 20x 40x同速
未来,在云端化和智能化技术的推动下,病理应该是更加智能的病理。病理医生可以在任何位置打开计算机,查看前一晚经过智能化处理的数据及初步报告,做进一步审核确认就可以完成诊断。经云端发出后,智能工具帮助检查错误、整合报告、提出临床规范意见,然后格式化的报告就产生了。
在这样一条更加智能更加科学的数字化病理道路上,滨松会一直秉持初心,致力于利用先进的技术为病理医生和患者带去福音,加速数字病理临床应用的步伐。
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