Ezra, the healthcare AI startup revolutionizing early cancer detection through full-body MRI screening, today announced new 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its advanced Ezra Flash AI model. This new FDA achievement builds on its previous 510(k) clearance recognized in June 2023 and enables Ezra to empower its partner imaging facilities with faster, lower-cost imaging..

Ezra，这家通过全身MRI筛查革新早期癌症检测的医疗AI初创公司，今天宣布其先进的Ezra Flash AI模型获得了美国食品药品监督管理局（FDA）的新510(k)许可。这一新的FDA成果建立在2023年6月获得的先前510(k)许可的基础上，使Ezra能够为其合作的影像机构提供更快、成本更低的成像服务。

With this latest product update, Ezra Flash, a Class II medical device, allows Ezra to enhance the quality of imaging not only for neuro MRI images but also for the abdomen and pelvis, expanding its applicability across the entire body. This advancement operates under Ezra's commitment to make cancer screening more accessible and affordable, and will enable the company to accelerate the scan time for its Ezra Full Body Flash scan..

通过这次最新的产品更新，Ezra Flash这款II类医疗设备不仅提升了神经MRI图像的成像质量，还扩展到腹部和骨盆区域，从而增强了其全身适用性。这一进步体现了Ezra致力于使癌症筛查更加普及和经济实惠，并将帮助公司加快其Ezra全身Flash扫描的速度。

'This FDA clearance marks another milestone in our journey towards making affordable and fast full-body MRIs a reality,' said Emi Gal, founder and CEO of Ezra. 'Our goal is to launch a 15-minute, $500 full body MRI scan in 2026, and this new FDA clearance is an important step in that direction.”

“这一FDA许可标志着我们在实现经济实惠且快速的全身MRI旅程中又迈出了一个里程碑，”Ezra创始人兼首席执行官Emi Gal表示。“我们的目标是在2026年推出15分钟、500美元的全身MRI扫描，而这项新的FDA许可是朝此方向迈出的重要一步。”

Key advancements to Ezra Flash include:

Ezra Flash 的主要进展包括：

Image Quality Improvement: The latest FDA clearance improves image quality by reducing noise within the image while maintaining diagnostic integrity.

图像质量改进：最新的FDA认证通过减少图像中的噪声来提高图像质量，同时保持诊断的完整性。

Enhanced Imaging for Radiologist Analysis: Ezra’s improved image quality allows for more precise analyses, boosting radiologists’ ability to provide clear and actionable insights to patients.

增强的影像以供放射科医生分析：Ezra 提升的图像质量使分析更加精确，增强了放射科医生为患者提供清晰且可操作见解的能力。

Maintained Regulatory Standards: As with Ezra’s previous clearance, this FDA approval reassures that Ezra Flash meets rigorous health and safety standards, making it a trusted option for both radiologists and patients.

维持监管标准：正如Ezra之前的审批一样，此次FDA的批准再次确认Ezra Flash符合严格的健康和安全标准，成为放射科医生和患者值得信赖的选择。

'The FDA clearance of Ezra Flash represents a significant advancement in making AI-powered cancer screening more accessible,' said Daniel K. Sodickson, MD, PhD, Chief Scientific Advisor at Ezra. 'This technology enables faster, more accurate early cancer detection, ultimately giving patients and their doctors clearer insights for making informed healthcare decisions.'.

“Ezra Flash获得FDA批准，代表着在使人工智能驱动的癌症筛查更加普及方面取得了重大进展，”Ezra首席科学顾问Daniel K. Sodickson博士表示。“这项技术能够实现更快、更精准的早期癌症检测，最终为患者及其医生提供更清晰的信息，以做出明智的医疗决策。”

Ezra is the first company globally to leverage AI across all three key components of the cancer screening process: imaging, analysis and reporting. The Ezra Flash AI enables Ezra to enhance MR image quality, Ezra AI assists radiologists when interpreting MRI images (FDA-cleared for Prostate MRI images), and Ezra Reporter AI creates an easily digestible translation of radiology reports that assist medical professionals in communicating screening results to Ezra members.

Ezra是全球首家在癌症筛查流程的三个关键环节——成像、分析和报告——全面运用人工智能的公司。Ezra Flash AI能够提升MR图像质量，Ezra AI在解读MRI图像时为放射科医生提供协助（已获FDA批准用于前列腺MRI图像），而Ezra Reporter AI则将放射学报告转化为易于理解的形式，帮助医疗专业人员向Ezra会员传达筛查结果。

About 6% of scanned Ezra members have identified potential cancer..

大约6%的扫描过的以斯拉成员已经确认了潜在的癌症。

Ezra’s technology is available at 74 locations in 29 cities across the U.S.

Ezra的技术在美国29个城市的74个地点可用。

About Ezra:

关于以斯拉：

Founded in 2018 by serial entrepreneur Emi Gal, Ezra combines AI technology with medical expertise to revolutionize cancer screening. The company has raised $44m in funding, including a recent $21m round led by Healthier Capital. For more information, visit www.ezra.com.

Ezra由连续创业者Emi Gal于2018年创立，结合人工智能技术和医学专业知识，致力于革新癌症筛查。公司已筹集4400万美元资金，其中包括Healthier Capital领投的最近一轮2100万美元融资。欲了解更多信息，请访问www.ezra.com。

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Source: globenewswire.com

来源：globenewswire.com