Asensus Surgical Receives FDA 510(k) Clearance for Senhance Surgical System in Urology
Asensus Surgical Receives FDA 510(k) Clearance for Senhance Surgical System in Urology
RESEARCH TRIANGLE PARK, N.C., July 23, 2024 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a global leader of innovative digital solutions for the operating room, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for an expanded indication to treat adult and pediatric Urology patients with the Senhance Surgical System.
2024年7月23日,北卡羅來納州研究三角區(RESEARCH TRIANGLE PARk)(全球新聞通訊社)-- Asensus Surgical,Inc.(美國紐交所:ASXC)是手術室創新數字解決方案的全球領導者。今天宣佈已從美國食品和藥物管理局("FDA")獲得510(k)許可證,以擴大適應成人和兒科泌尿科患者的Senhance員工肖像系統。
"This FDA clearance marks another milestone for Asensus Surgical and represents an additional indication expansion in the U.S. market," said Anthony Fernando, Asensus Surgical President and CEO. "The Senhance System's precision and advanced digital capabilities make it uniquely suited for urological procedures, offering surgeons the benefit of digital tools and smaller instrumentation. We are excited to bring this technology to urologists and their patients across the United States."
"這個FDA批准標誌着Asensus Surgical的又一個里程碑,並代表了美國市場的另一個適應性擴展," Asensus Surgical總裁兼首席執行官Anthony Fernando表示:"Senhance系統的精度和先進的數字功能使其唯一適合泌尿科手術,爲外科醫生提供數字工具和更小的器械的好處。我們很高興將這項技術帶給美國的泌尿科醫生和他們的患者。"
Healthcare providers perform upwards of 185,000 urological surgical procedures each year in the United States.* While the Senhance System has been successfully utilized for Urology procedures outside the U.S. for several years, this expanded indication will open the door to this important specialty to leverage the advantages of the Senhance System in the U.S. patient population.
在美國每年進行超過185,000次泌尿科手術。*雖然Senhance系統在美國以外的泌尿科手術中已經成功使用了幾年,但這個擴大的適應症將爲該重要專業開啓門戶,利用Senhance系統在美國患者人群中的優勢。
Chester Koh MD, MBA, FACS, FAAP, a pediatric urologist and director of the Pediatric Robotic Surgery Program and Professor at Baylor College of Medicine in Houston, Texas noted that, "With a full suite of 3mm and 5mm instruments and digital integrations, the Senhance Surgical System combines the benefits of robotics and minimally invasive surgery. This is an exciting step in the evolution of Urological surgery for both adult and pediatric patients."
德克薩斯州休斯頓市貝勒醫學院(Baylor College of Medicine)的兒科泌尿學家,小兒機器人手術計劃的主任、教授Chester Koh MD、MBA、FACS、FAAP指出:"Senhance手術系統擁有完整的3毫米和5毫米器械以及數字集成的優點,結合機械臂和微創手術的好處。這是泌尿科手術發展的一大進步,無論是成人還是兒童患者。"
![big](https://newsfile.futunn.com/public/NN-PersistNewsContentImage/7781/20240724/0-e82b5fb425b06ad607aea2b014265224-0-a1cf201572da36ce3ce4dbaf9d157c2c.jpg/big)
The Senhance Surgical System is designed to increase surgeon control and reduce variability through Augmented Intelligence and deep learning capabilities.
Senhance手術系統旨在通過增強智能和深度學習功能,提高外科醫生的控制力和降低可變性。
About Asensus Surgical, Inc.
關於Asensus Surgical, Inc.
Asensus Surgical is revolutionizing surgery with the first intra-operative Augmented Intelligence technology approved for use in operating rooms around the world. Recognized as an award-winning leader in digital technology, Asensus is committed to making surgery more accessible and predictable while delivering consistently superior outcomes. The Company's novel approach to digitizing laparoscopy has led to system placements globally. Led by engineers, medical professionals, and industry luminaries, Asensus is powered by human ingenuity and driven by collaboration. To learn more about the Senhance Surgical System and the new LUNA System in development, visit .
Asensus Surgical正在通過全球首次獲得用於手術室的術中增強型智能技術,推動手術革新。作爲數字技術領域的獲獎領導者,Asensus致力於在提高手術可達性和預測性的同時,實現持續卓越的成果。該公司數字化腹腔鏡的創新方法已在全球實現系統的放置。Asensus由工程師、醫學專業人士和行業泰斗的支持,秉承人類的智慧和合作精神。欲了解更多關於Senhance手術系統和正在開發中的全新LUNA系統的信息,請訪問 。
Forward-Looking Statements
前瞻性聲明
This press release includes statements relating to Asensus, the Senhance Surgical System and the FDA's clearance for an expanded indication to treat adult and pediatric Urology patients with the Senhance Surgical System. These statements and other statements regarding our future plans and goals constitute "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the FDA clearance will represent another expansion in our market, and whether the Senhance Surgical System's precision and advanced digital capabilities make it uniquely suited for urological procedures, offering surgeons the benefit of digital tools and smaller instrumentation. For a discussion of the risks and uncertainties associated with the Company's business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
本新聞稿包括有關Asensus、Senhance手術系統和FDA對通過擴大適應成人和兒科泌尿科患者的Senhance手術系統的許可的聲明。這些聲明和關於我們未來計劃和目標的其他聲明構成了1933年《證券法》第27A條和1934年《證券交易法》第21E條所規定的"前瞻性聲明",並旨在符合1995年《私人證券訴訟改革法》所建立的豁免責任安全港。由於一些常難以預測和我們無法控制的風險和不確定性,這些聲明可能導致結果與期望有所不同,包括FDA許可是否表示我們市場的另一個擴張,以及Senhance手術系統的精度和先進的數字功能是否使其唯一適合泌尿科手術,爲外科醫生提供了數字工具和更小的器械的好處。對於與公司業務相關的風險和不確定性的討論,請查閱我們提交給證券交易委員會(SEC)的文件,包括我們於2024年3月21日提交給SEC的2013年年報10-k和我們提交給SEC的其他文件。請謹慎對待這些前瞻性聲明,這些聲明基於本新聞發佈日期的我們的預期,並僅作爲本新聞發佈日期的原始日期的聲明。我們不承擔任何公開更新或修訂任何前瞻性聲明的義務,無論是因爲新信息、未來事件或其他原因。
ASENSUS SURGICAL CONTACT:
ASENSUS SURGICAL聯繫方式:
INVESTORS
Mark Klausner or Mike Vallie
ICR Westwicke
invest@asensus.com
443-213-0499
投資者
Mark Klausner或Mike Vallie
ICR Westwicke
invest@asensus.com
443-213-0499
MEDIA
Dan Ventresca
Matter Communications
AsensusPR@matternow.com
617-874-5488
媒體
Dan Ventresca
Matter Communications
AsensusPR@matternow.com
617-874-5488
*Urology Market data forecasted for 2023 from DRG Clarivate Laparoscopic Market Insights - December 2021
*Urology Market data forecasted for 2023 from DRG Clarivate Laparoscopic Market Insights - December 2021
A photo accompanying this announcement is available at
此公告附帶的照片
The Senhance Surgical System
Senhance手術系統
![big](https://newsfile.futunn.com/public/NN-PersistNewsContentImage/7781/20240724/0-e82b5fb425b06ad607aea2b014265224-4-cb7242f9c864e9624cf539aebf262b27.jpg/big)
The Senhance Surgical System is designed to increase surgeon control and reduce variability through Augmented Intelligence and deep learning capabilities.
Senhance手術系統旨在通過增強智能和深度學習功能,提高外科醫生的控制力和降低可變性。
Source: Asensus Surgical, Inc.
來源:Asensus Surgical,Inc。
譯文內容由第三人軟體翻譯。