Virtuoso内窥镜机器人系统获美国食药局De Novo授权：为腔内手术机电系统首个新分类，获准整块切除成人膀胱病变
纳什维尔，田纳西州 — Virtuoso Surgical 公司 11 月 10 日宣布，美国食品药品管理局已为其 Virtuoso 内窥镜系统授予 De Novo 授权。该系统为食药局新设分类腔内手术用机电手术系统中的首款器械，获准用于成人膀胱病变的整块切除，以取得含膀胱逼尿肌在内的组织标本，协助膀胱癌的诊断评估。该系统此前于 2025 年 9 月获食药局突破性器械认定。
公司介绍，该系统在硬性内窥镜尖端装有两条针头大小的机械臂，由超弹性镍钛合金同心管制成，可跟随外科医生的手部动作，一臂提起并牵拉组织与肿瘤，另一臂在其下方切割，使经尿道手术具备双手灵巧操作。
临床数据方面，公司资助的 VIABLE 研究首批 20 名患者在香港中文大学完成治疗：切除病变中 94% 检出逼尿肌，高于研究设定的 60% 目标，也高于已发表文献中传统经尿道膀胱肿瘤切除术约 70% 的中位水平；93% 的恶性病变可评估手术切缘；术中无不良事件。公司称数据为单中心初步结果。
背景数据方面，美国癌症协会估计 2026 年美国将有约 84530 人新确诊膀胱癌。公司计划 2027 年在美领先泌尿外科中心重点推出该系统；妇科、肺科与神经外科等其他用途目前仍属研究性质，未获食药局授权。本稿只报道授权与研究事实，不作个体诊疗建议。
Virtuoso Endoscopy System Receives FDA De Novo Authorization: The First Device in a New Classification for Endoluminal Surgical Systems, Authorized for En Bloc Resection of Bladder Lesions in Adults
Nashville, Tennessee — Virtuoso Surgical announced on November 10 that the U.S. Food and Drug Administration has granted De Novo authorization for the Virtuoso Endoscopy System. It is the first device in a new FDA classification, electromechanical surgical systems for endoluminal surgical procedures, and is authorized for en bloc resection of bladder lesions in adult patients to obtain tissue samples, including detrusor muscle, to assist in the diagnostic evaluation of bladder cancer. The system previously received FDA Breakthrough Device Designation in September 2025.
The company says the system places two needle-sized robotic arms at the tip of a rigid endoscope. Made of superelastic concentric nitinol tubes, the arms follow the surgeon's hand motions from a console, with one arm lifting and retracting tissue and the tumor while the other dissects beneath it.
In the first 20 patients of the company-sponsored VIABLE study, all treated at The Chinese University of Hong Kong, detrusor muscle was present in 94 percent of removed lesions, above the study 60 percent performance goal and the median rate of approximately 70 percent reported across published studies of conventional transurethral resection. Surgical margins could be evaluated in 93 percent of malignant lesions, and there were no intraoperative adverse events. The company notes the results are preliminary and from a single site.
For background, the American Cancer Society estimates about 84,530 Americans will be newly diagnosed with bladder cancer in 2026. The company plans a focused U.S. launch at leading urology centers in 2027, and says uses in gynecology, pulmonary procedures and neurosurgery remain investigational and are not FDA-authorized. This report covers the authorization and study facts only and offers no individual treatment advice.
来源：Business Wire
发布：GSM·美国（发布链接）
图片来源：食品药品监督固定图库（GSM asset-packs）
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