Bracco脑动脉瘤软件UPTUNITY获FDA许可：可在头部CTA影像上识别大于3毫米的动脉瘤并追踪变化
Bracco 与 Avicenna.AI 于11月13日宣布，两家公司合作开发的软件 UPTUNITY | Aneurysm 已获得美国食品药品监管局（FDA）的 510(k) 许可。这是 Bracco 新推出的 UPTUNITY 临床决策支持软件组合中的首款产品，用于在脑动脉计算机断层血管成像（CTA）影像上，辅助医疗专业人员检测和评估脑动脉瘤。
据两家公司介绍，该软件嵌入放射科医生既有的阅片工作流程，作为同步阅读辅助工具，识别头部 CTA 影像上大于3毫米的疑似囊状脑动脉瘤，并提供其存在、位置和大小等信息，供医生评估和定性。对于已知动脉瘤，软件的随访功能可做定量测量，并把不同次检查的结果相互对比，帮助医生判断动脉瘤随时间的变化。
两家公司表示，美国约每50名成年人中就有1人患有未破裂脑动脉瘤，这类病变通常没有症状，且在脑动脉 CTA 影像上并不容易发现，常在为其他问题做影像检查时被偶然查出。软件给出的信息须与 CTA 影像本身一并研判，临床决定仍由医生作出；该软件无意替代完整的患者评估或合格医生的复核，也不应被单独用作作出或确认诊断的依据。
Bracco Americas 营销与商业运营执行副总裁 Cosimo DePinto 表示，头部 CTA 上一个小的偶然发现的动脉瘤，在阅片清单不断变长时很容易被漏掉，这款软件在放射科医生熟悉的阅读环境中工作，帮助找出藏在 CT 扫描中的动脉瘤，而临床决定仍掌握在放射科医生手中。
此次许可涉及两个 510(k) 编号：K262062 与 K262147，对应的商业名称分别为 UPTUNITY | Aneurysm Detection 与 UPTUNITY | Aneurysm Management，其技术基础为 Avicenna.AI 的 CINA-Aneurysm 与 CINA-Aneurysm+。两家公司于2026年3月宣布战略合作，推进超级智能（SI）在对比增强计算机断层成像中的应用；目前正筹备该软件在美国的商业上市，推广与商业分发由 Avicenna.AI 负责。该软件将于11月29日至12月3日在 Chicago 举行的北美放射学会（RSNA）2026年会上展示。
（来源：Bracco 与 Avicenna.AI）
Bracco's UPTUNITY Brain Aneurysm Software Cleared by FDA: Flags Aneurysms Over 3 mm on Head CTA and Tracks Changes Over Time
Bracco and Avicenna.AI announced on November 13 that their jointly developed software, UPTUNITY | Aneurysm, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). It is the first offering in Bracco's new UPTUNITY portfolio of clinical decision support solutions, designed to support medical specialists in detecting and assessing brain aneurysms on cerebral arteries computed tomography angiography (CTA) images.
According to the companies, the software integrates into the radiologist's existing reading workflow as a concurrent reading aid. It identifies suspected saccular brain aneurysms greater than 3 mm on head CTA images and provides information about their presence, location and size for assessment and characterization. For known aneurysms, its follow-up functionality provides quantitative measurements and comparison between examinations to assess changes over time.
The companies said an estimated one in 50 U.S. adults has an unruptured brain aneurysm, a condition that is often asymptomatic. Aneurysms can be difficult to detect on cerebral arteries CTA and may be discovered incidentally during imaging performed for other concerns. The software provides information for use alongside review of the CTA images, while physician control over clinical decision-making is maintained; it is not intended to replace a full patient evaluation or a qualified physician's review and should not be solely relied upon to make or confirm a diagnosis.
"A small incidental aneurysm on a head CTA can easily be overlooked when the worklist keeps growing," said Cosimo DePinto, Executive Vice President, Marketing & Commercial Operations at Bracco Americas. "UPTUNITY | Aneurysm works inside the reading environment radiologists already know and helps find the aneurysm hiding in the CT scan. The clinical decision stays where it belongs: with the radiologist."
The clearance covers two 510(k) numbers, K262062 and K262147, whose commercial names are UPTUNITY | Aneurysm Detection and UPTUNITY | Aneurysm Management, built on Avicenna.AI's CINA-Aneurysm and CINA-Aneurysm+. The two companies announced their strategic partnership in March 2026 to advance super intelligence (SI) applications in contrast-enhanced computed tomography. They are now preparing the commercial introduction of the software in the United States, with Avicenna.AI leading promotion and commercial distribution. The software will be showcased at the Radiological Society of North America (RSNA) 2026 Annual Meeting, taking place November 29 to December 3 in Chicago.
(Source: Bracco and Avicenna.AI)
来源：Bracco 与 Avicenna.AI
发布：GSM·美国（发布链接）
图片来源：图：美国食品药品监管局（FDA）总部大楼（固定图库）。FDA 官方图。 / The U.S. Food and Drug Administration headquarters (file photo). Photo: U.S. Food and Drug Administration.
GSM Global · 本篇英文版 English edition of this story
