LA CIOTAT, France, July 3, 2024 /PRNewswire/ -- Avicenna.AI, a leading medical imaging AI company, has received Medical Device Regulation (MDR) certificate for five of its algorithms from certification body BSI Medical Devices. This development means the company's product portfolio is fully compliant with the European Union's MDR 2017/745, which is now mandatory for medical device companies that want to provide their solutions in Europe..

拉西奥塔，法国，2024年7月3日/PRNewswire/--阿维森纳。AI是一家领先的医学成像AI公司，已从认证机构BSI medical Devices获得了五种算法的医疗器械监管（MDR）证书。这一发展意味着该公司的产品组合完全符合欧盟MDR 2017/745，该MDR现在是希望在欧洲提供解决方案的医疗器械公司的强制性要求。。

The MDR was introduced to update the EU's regulations for medical devices, addressing safety issues and the recent emergence of AI tools and software as a medical device (SaMD), which did not exist when the old regulations were created. Ensuring MDR compliance is a critical component of obtaining and maintaining CE-mark status, which allows a device to be freely traded in the EU..

引入MDR是为了更新欧盟的医疗器械法规，解决安全问题以及最近出现的人工智能工具和软件作为医疗器械（SaMD），而旧法规制定时并不存在。确保MDR合规性是获得和维护CE标志状态的关键组成部分，CE标志状态允许设备在欧盟自由交易。。

Compared to the previous Medical Device Directive (MDD), the MDR has a wider scope and more stringent requirements. It emphasizes clinical evaluation, post-market surveillance, device traceability, rigorous technical documentation, and risk management. These measures aim to enhance patient safety and ensure high standards for medical devices, including AI and software-based solutions..

与之前的医疗器械指令（MDD）相比，MDR具有更广的范围和更严格的要求。它强调临床评估、上市后监测、设备可追溯性、严格的技术文档和风险管理。这些措施旨在提高患者安全，确保医疗设备的高标准，包括人工智能和基于软件的解决方案。。

Avicenna.AI's products have been certified as Class IIb medical devices, which requires a high level of clinical validation. The certified products include the company's suite of AI tools for neurovascular conditions, as well as its suite of algorithms for vascular conditions.

阿维森纳。AI的产品已被认证为IIb类医疗器械，这需要高水平的临床验证。认证产品包括该公司针对神经血管疾病的AI工具套件，以及针对血管疾病的算法套件。

'Obtaining MDR certification is a significant milestone for Avicenna.AI,' said Stéphane Berger, Regulatory Manager at Avicenna.AI. 'It demonstrates our commitment to meeting the highest standards of medical device safety and performance. This certification not only reinforces our dedication to compliance but also assures our customers of the quality and reliability of our AI product portfolio.'.

“获得MDR认证对Avicenna来说是一个重要的里程碑。Avicenna的监管经理斯特凡·伯杰（StéphaneBerger）说。AI。“这表明我们致力于达到医疗器械安全和性能的最高标准。该认证不仅加强了我们对法规遵从性的承诺，而且还确保了我们的客户对AI产品组合的质量和可靠性。”。

The company's MDR-certified AI tools include algorithms for intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), quantification of stroke severity (CINA-ASPECTS), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and opportunistic cases of pulmonary embolism (CINA-iPE). All the products are also CE-marked and FDA-cleared..

该公司经MDR认证的AI工具包括颅内出血（CINA-ICH），大血管闭塞（CINA-LVO），卒中严重程度量化（CINA-ASPECTS），主动脉夹层（CINA-AD），肺栓塞（CINA-PE）和肺栓塞机会性病例（CINA-iPE）。所有产品都有CE标志和FDA批准。。

'Crucially, despite the differences in SaMD regulatory requirements between authorities in the US and Europe, we are consistently achieving both FDA and CE mark clearance for our AI products,' added Berger.

伯杰补充道：“至关重要的是，尽管美国和欧洲当局在SaMD监管要求上存在差异，但我们一直在为我们的人工智能产品取得FDA和CE标志的许可。”。

All of Avicenna.AI's AI tools are seamlessly integrated into radiologists' clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists.

整个阿维森纳。AI的AI工具无缝集成到放射科医生的临床工作流程中，通过放射科医生已经使用的系统自动触发和报告算法结果。

About Avicenna.AIFounded in 2018, Avicenna.AI specializes in providing healthcare AI solutions that utilize deep learning to identify, detect, and quantify severe pathologies from CT medical images. Co-founded by Cyril Di Grandi, a successful entrepreneur who previously co-founded Olea Medical, and Dr.

。Aicenna成立于2018年。AI专门提供医疗保健AI解决方案，利用深度学习从CT医学图像中识别，检测和量化严重病理。由CyrilDiGrandi和Dr。

Peter Chang, an internationally recognized radiologist, and an expert in AI and deep learning, Avicenna.AI aims to accelerate therapeutic decision-making processes and enhance patient outcomes through its AI-based radiology solutions. For additional details, stay connected with us on social media and explore Avicenna.AI's website at www.avicenna.ai. .

彼得·张（PeterChang），国际公认的放射科医生，人工智能和深度学习专家，Avicenna。AI旨在通过其基于AI的放射学解决方案加速治疗决策过程并提高患者预后。有关更多详细信息，请在社交媒体上与我们保持联系，并探索Avicenna。AI的网站：www.avicenna.AI。