YOKNEAM, Israel, Sept. 11, 2023 /PRNewswire/ -- Limaca Medical ('Limaca') announced today that its Precision GI™ Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the U.S. Food and Drug Administration ('FDA'). This follows Limaca's receipt of FDA Breakthrough Device Designation for its Precision GI™..

以色列YOKNEAM，2023年9月11日/PRNewswire/-利马卡医疗（'Limaca'）今天宣布其精确地理标志™ 内镜超声（EUS）活检装置从美国食品和药物管理局（'FDA'）获得510（k）的许可。这是继利马卡收到FDA突破性设备指定的精确GI之后™..

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Limaca Medical’s Precision GITM Endoscopic Biopsy Device with motorized, automated rotational cutting needle for high-quality tissue acquisition.

利马卡医疗公司的Precision GITM内窥镜活检装置，配有电动自动旋转切割针，可实现高质量的组织采集。

Precision GI™ obtains biopsies for definitive diagnosis of pancreatic cancer and other life-threatening GI cancers more quickly and less traumatically than current products. The automated device is designed to provide for more efficient and effective diagnosis of GI cancers by yielding significantly superior quality and quantity of diagnostically relevant biopsy tissue.  Limaca's First-In-Human EUS-Biopsy cases in suspect pancreatic cancer patients was published by iGIE, on 26 April 2023..

精确的GI™ 获得活组织检查，以便比现有产品更快，更轻松地诊断胰腺癌和其他威胁生命的胃肠癌。该自动化装置旨在通过产生显着优异的诊断相关活检组织的质量和数量来提供GI癌症的更有效和有效的诊断。利马卡于2023年4月26日由iGIE发布了首例可疑胰腺癌患者的人体EUS活检病例。。

'While all existing endoscopic ultrasound fine needle biopsy (EUS-FNB) devices require manual hand operation, Precision GI™ features a unique motorized, automated rotational cutting needle for successful, safe, and high-quality tissue acquisition. Today's endoscopic biopsy devices have limitations in consistently obtaining quality tissue with sufficient quantity, which can result in sample tissue fragmentation, inadequate tissue amount, and blood contamination,' commented Prof.

'虽然所有现有的内窥镜超声细针穿刺活检（EUS-FNB）设备都需要手动操作，但精密GI™ 具有独特的电动自动旋转切割针，可成功，安全和高质量的组织采集。教授评论说，今天的内窥镜活检装置在持续获得足够数量的优质组织方面存在局限性，这可能导致样本组织碎裂，组织量不足和血液污染。

Iyad Khamaysi, MD, Director of the Invasive Endoscopy Unit at the Rambam Health Care Campus. .

Rambam医疗保健园区侵入性内窥镜检查部门主任Iyad Khamaysi博士。 .

Assaf Klein, Limaca CEO, commented, 'Our first series of patients have demonstrated that Precision GI™ enables obtaining contiguous intact core tissue samples adequate for definitive diagnoses of pancreatic lesions. The clean, non-contaminated tissue samples provide a high percentage of tumor content, with less blood and extraneous fluids.

利马卡首席执行官阿萨夫·克莱因评论说：“我们的第一批患者已经证明了精确胃肠道™ 能够获得足以确定胰腺病变诊断的连续完整核心组织样本。清洁，未污染的组织样本提供高百分比的肿瘤含量，血液和外来液体较少。

FDA clearance allows us to bring Precision GI™ to market to fulfill our mission to always achieve precise, efficient, and definitive biopsy samples.'Carl Rickenbaugh, Limaca Vice Chair, added, 'We are pleased with FDA's clearance of Precision GI™, following our FDA Breakthrough Device Designation. We are dedicated to our mission to provide a far better endoscopic biopsy experience for the endoscopist and patient, with the goal of achieving faster, more efficient biopsy yield with highly consistent results.

FDA的批准使我们能够带来精确的GI™ 市场以履行我们的使命，始终获得精确，有效和确定的活检样本。”利马卡副主席Carl Rickenbaugh补充说：“我们对FDA批准的精确GI感到满意™, 遵循我们的FDA突破性设备指定。我们致力于我们的使命，为内镜医师和患者提供更好的内镜活检体验，目标是实现更快，更有效的活检结果和高度一致的结果。

We look forward to soon bringing Precision GI™ to patients in the US.'About Limaca Medical Limaca Medical Ltd is a privately held company dedicated to improving endoscopic biopsy results for patients facing potentially life-threatening gastroenterology and pulmonary cancers. Limaca's experienced team of engineers, clinicians, and business professionals have track records of innovating, developing, and commercializing specialized medical devices.https://limaca-medical.comPhoto - https://mma.prnewswire.com/media/2206276/Limaca_device.jpgMedia contact:Carl Rickenbaugh  [email protected]SOURCE Limaca Medical.

我们期待很快带来精确的GI™ “关于美国患者”。关于利马卡医疗利马卡医疗有限公司是一家私营公司，致力于改善面临潜在威胁生命的胃肠病学和肺癌患者的内镜活检结果。利马卡经验丰富的工程师，临床医生和商业专业人员团队拥有创新，开发和商业化专业医疗器械的记录。https://limaca-medical.comPhoto - https://mma.prnewswire.com/media/2206276/Limaca_device.jpgMedia联系方式：Carl Rickenbaugh[电子邮件保护]来源Limaca Medical。