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FDA 510(k) 許可確立 Copan 的 PhenoMATRIX® 廣泛預期用途,拓展臨床微生物學檢測能力

加州穆列塔2026年2月17日 /美通社/ -- Copan Group 今天宣佈,旗下與 WASPLab® 全實驗室自動化系統結合應用的自動化圖像評估軟件 PhenoMATRIX®,已取得 FDA 的 510(k) 核准,列為美國 Class II 醫療器材。 PhenoMATRIX® 支援培養皿的自動化圖像分類,最終的評估工作由受過專業訓練的實驗室人員負責。 PhenoMATRIX 是一款體外診斷軟件,運用人工智能,配合實驗室定義的規則和臨床資訊,自動將細菌培養皿的影像分類,有助實驗室人員簡化培養皿的審查工作,同時保留專家的監督角色。 是次獲批的預期用途涵蓋血瓊脂、巧克力瓊脂、MacConkey 瓊脂,以及 CHROMagar 定向培養基培養皿。其技術透過檢測微生物生長、估算菌落數目,並根據菌落的表型特徵來區分分離株,實現以圖像為本的半定量及定性分析。 Copan Diagnostics 行政總裁 Fabrizio Mazzocchi 說:「這次獲批對 Copan 和美國的微生物實驗室來說,標誌着重要里程碑。 PhenoMATRIX 匯集多年來的科研成果和真實世界數據,旨在支援實驗室,以及其在病人護理方面擔當的關鍵角色。」 一直以來,PhenoMATRIX 作為 Copan 全套實驗室自動化解決方案的其中一環,已在全球應用多年,在美國境外更用於自動化圖像審查及自動發佈結果等流程。然而,是次批准正式確立其在美國的預期用途,當地的圖像最終評估及結果判定,仍由受過專業訓練的實驗室人員執行。 重要的是,此番 FDA 授予的預期用途,乃突破單一應用演算法的革新之舉。其功能橫跨多種培養基培養皿,並將圖像分析與病人數據融會貫通,為實驗室的臨床微生物學審閱工作,提供強大輔助。 Copan 自動化部門 Copan WASP 的行政總裁 Mario Savarese 補充道:「這項卓越成就,是團隊通力合作的成果。 我們的監管事務、研發、科學事務、質素監控及商業團隊,為這次申請不辭勞苦,全力以赴。 這次獲批,是對他們全情投入及 Copan 長遠願景的最佳證明。」 Copan 會持續投放資源,籌備未來的申請,務求將 PhenoMATRIX 的應用範圍擴展至更多範疇及培養皿類型,進一步彰顯其對創新及與臨床微生物學界緊密合作的不懈追求。 如欲了解更多資訊,請瀏覽 copanusa.com。 關於 Copan Diagnostics, Inc.  Copan Diagnostics 是 Copan Group 的旗下成員,而 Copan Group 是採集與運送系統的頂尖製造商。 Copan 秉持協作精神,開發出多項突破性技術,例如 FLOQSwabs®、ESwab®、UTM® Universal Transport Medium™,以及結合人工智能的全實驗室自動化系統 WASPLab®。 Copan 不斷推陳出新,革新樣本採集及運送系統,以及實驗室自動化技術,以助醫療機構提升病人護理質素。 Copan 系統會為培養皿擷取高解像度影像,以進行數碼評估。  

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 604 加入收藏 :
FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities

MURRIETA, Calif., Feb. 17, 2026 /PRNewswire/ -- Copan Group announced today that PhenoMATRIX®, its automated image assessment software used with WASPLab® full laboratory automation, received FDA 510(k) clearance as a Class II device in the United States. PhenoMATRIX® supports automated image sorting of culture plates, with final assessment performed by trained laboratory personnel. PhenoMATRIX is an in vitro diagnostic software that uses artificial intelligence with laboratory-defined rules and clinical information to automatically sort images of bacterial culture plates, helping laboratory professionals streamline plate review while maintaining expert oversight. The cleared intended use includes blood-based, chocolate and MacConkey agars, as well as CHROMagar orientation culture media plates, enabling semi-quantitative and qualitative image-based analysis through detection of microbial growth, estimation of colony counts, and differentiation of isolates based on phenotypic colony characteristics. "This clearance represents a major milestone for Copan and microbiology laboratories in the United States," said Fabrizio Mazzocchi, CEO of Copan Diagnostics. "PhenoMATRIX builds on years of scientific development and real-world data to support laboratories and the critical work they do in patient care." While PhenoMATRIX has been used globally for years as part of Copan's full laboratory automation solutions, including automated image review and auto-release workflows outside the United States, this clearance formally establishes its intended use in the U.S., where final image assessment and result decisions are performed by trained laboratory personnel. Importantly, the FDA-cleared intended use represents an expansion beyond single-application algorithms, supporting multiple culture media plate types and integrating image analysis with patient data to assist laboratories in clinical microbiology review. "This achievement is the result of an extraordinary collaborative effort," added Mario Savarese, CEO of Copan WASP, Copan's automation division. "Our Regulatory, R&D, Scientific Affairs, Quality, and Commercial teams worked tirelessly to support this submission. This clearance is a testament to their dedication and Copan's long-term vision." Copan continues to invest in future submissions to expand the scope of PhenoMATRIX across additional applications and plate types, reinforcing its commitment to innovation and partnership with the clinical microbiology community. For more information, visit copanusa.com. About Copan Diagnostics, Inc.  Copan Diagnostics is part of Copan Group, a leading manufacturer of collection and transport systems. Through its collaborative approach, Copan has developed breakthrough technologies such as FLOQSwabs®, ESwab®, UTM® Universal Transport Medium™, and WASPLab®, Full Laboratory Automation with Artificial Intelligence. Copan continues to innovate and transform collection and transport systems, and laboratory automation, helping healthcare providers improve patient care. The Copan system captures high-resolution images of culture plates for digital evaluation.      

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 263 加入收藏 :
WIDIA Turns 100: Defining and Celebrating a Century of Metal Cutting Solutions

PITTSBURGH, Feb. 17, 2026 /PRNewswire/ -- WIDIA, a trusted brand of Kennametal Inc. and a global leader in high performance metal cutting solutions, is celebrating 100 years. Since its founding in 1926, the WIDIA name has been synonymous with unmatched durability, cutting-edge technology and proven performance, delivering milling, holemaking and tapping solutions, as well as tooling systems to shops across a range of industries and applications. From pioneering tungsten carbide tooling to introducing advanced coated inserts, WIDIA has consistently set benchmarks in manufacturing technology. Over the decades, the brand expanded globally, integrated trusted sub-brands like Hanita and GTD, and has continued to deliver solutions that remain essential tools for shops of all sizes worldwide. Acquired by Kennametal Inc. in 2002, WIDIA remains a cornerstone brand within Kennametal's portfolio, driving metal cutting innovation and reliability for customers. "Turning 100 isn't just about looking back — it's about celebrating a legacy built on reliability and trust, and looking ahead to the future," said Dave Bersaglini, President of Metal Cutting, Kennametal. "Our customers – machinists, engineers and small to medium-sized shop owners – should expect WIDIA to keep advancing new, tougher tooling that works as hard as our customers do, for now and for the next generation. Celebrating 100 YearsTo commemorate this historic milestone, Kennametal is launching a series of WIDIA anniversary initiatives, including: 100 Days of Promotions and Special Incentives on powerhouse solutions like WCE4 solid carbide end mills and VSM890 shoulder mills #WIDIA100 exclusive anniversary merchandise and digital campaigns Customer engagement programs highlighting WIDIA's history and vision for the future Launch of a new global brand ambassador program "The WIDIA diamond emblem is much more than a logo – it's a hallmark of the toughness and durability that define every WIDIA tool," said Scott Etling, Vice President of Global Product Management, Kennametal. "It dates to the brand's beginnings 100 years ago, when WIDIA – taken from the German phrase 'Wie Diamant' or 'like diamond' – was first registered. That legacy still shapes the performance we deliver today." More anniversary initiatives will be announced on widia.com and its social media channels @widiatools in the coming months. About WIDIA, a Kennametal BrandSince 1926, WIDIA tooling combines high-performance engineering with real-world practicality. Offering a full spectrum of metal cutting solutions—from indexable milling and solid end mills to holemaking and threading systems—WIDIA helps machinists around the world tackle the toughest jobs, no matter the application. Available to customers globally through an authorized distributor network, WIDIA ensures local access and fast turnaround, as well as technical support. WIDIA is a brand of Kennametal Inc. Learn more at widia.com and follow @widiatools on LinkedIn, Facebook, Instagram and YouTube.

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 335 加入收藏 :
NYSE Content Update: USA TODAY Co. Rings Opening Bell to Celebrate Rebrand

NYSE issues a pre-market daily advisory direct from the trading floor. NEW YORK, Feb. 17, 2026 /PRNewswire/ --  The New York Stock Exchange (NYSE) provides a daily pre-market update directly from the NYSE Trading Floor. Access today's NYSE Pre-market update for market insights before trading begins.    USA TODAY Co. Celebrates Its Rebrand at NYSE Ashley Mastronardi delivers the pre-market update on February 17th Stocks are down Tuesday morning ahead of a shortened trading week after markets were closed yesterday for Presidents Day. Leaders from Payments platform, Bolt, and Digital Identity Company, Socure, are set to join NYSE Live to talk about their latest collaboration that they believe will Supercharge E-commerce identity. USA Today Co. (NYSE: TDAY) is celebrating its rebrand from Gannett with CEO Mike Reed joining NYSE Live to talk about the move and how it could impact the firm. Reckoner Capital Management Co-Founder and CEO John Kim will join Taking Stock this afternoon to share more about the products the firm is offering to investors. Opening BellUSA Today Co. (NYSE: TDAY) celebrates its rebrand and ticker change Closing BellReckoner Capital celebrates the listing of its new ETFs For market insights, IPO activity, and today's opening bell, download the NYSE TV App: TV.NYSE.com  BlackRock rang bell to honor Black History Month   Video - https://mma.prnasia.com/media2/2905158/NYSE_Feb_17_Market_Update_Video.mp4   

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 421 加入收藏 :
Frost & Sullivan: Nucleus Security Receives the 2025 Global Vulnerability Management Transformational Innovation Leadership Recognition for Excellence in AI-Powered Vulnerability Management

Frost & Sullivan recognizes this company for redefining vulnerability management through its AI-powered platform, data-agnostic architecture, and deeply integrated, automated processes SAN ANTONIO, Feb. 17, 2026 /PRNewswire/ -- Frost & Sullivan is pleased to announce that Nucleus Security has received the 2025 Global Transformational Innovation Leadership Recognition in the vulnerability and exposure management sector for its outstanding achievements in flexibility, automation, integration, and measurable customer impact. This recognition highlights Nucleus Security's consistent leadership in driving operational excellence, strengthening its global presence, and delivering customer-centered innovation in a dynamic cybersecurity landscape. Frost & Sullivan evaluates companies through a rigorous benchmarking process across two core dimensions: strategy effectiveness and strategy execution. Nucleus Security excelled in both, demonstrating its ability to align strategic initiatives with shifting cybersecurity requirements while executing with efficiency, scale, and clarity. Guided by a long-term growth strategy focused on data-agnostic models and automated processes, Nucleus Security has shown exceptional adaptability in a rapidly evolving global threat landscape. The company's sustained investment in operational efficiency and intelligent grouping for remediation has enabled it to scale effectively across diverse industries and organizational sizes worldwide. "Nucleus Security's data fabric architecture is central to its fast deployment model. With data-agnostic models for users, teams, assets, groups, and findings, the system accepts any metadata extensions, allowing organizations to track exactly what matters most to them," said Swetha Krishnamoorthi, Industry Principal, Cybersecurity, at Frost & Sullivan. Innovation remains central to Nucleus Security's approach. Its AI-powered platform, built on a scalable architecture with deep integration capabilities, supports a multistep, automated process—from ingestion to prioritization—that brings together fragmented security data, enabling risk-driven, contextualized decisions. The platform's flexibility and interoperability allow organizations to unify and operationalize vulnerability data, enhance collaboration across teams, and accelerate remediation with business-aligned prioritization. "We're honored by this recognition from Frost & Sullivan, but the real credit goes to our customers, who push us to solve the hardest operational challenges in security. Nucleus exists to simplify complexity, integrate seamlessly into existing environments, and help teams focus on what matters most. This award reflects our commitment to practical innovation that delivers real-world impact," said Tamir Hardof, Chief Marketing Officer, Nucleus Security. Nucleus Security's unwavering commitment to customer experience strengthens its position in the global market. Through a customer-first service model, the company simplifies program deployment, enables rapid onboarding, and maintains high levels of service reliability. Its robust ecosystem and partner-driven model ensure that organizations can implement scalable, compliant, and automated vulnerability management programs tailored to their security maturity and operational constraints. Frost & Sullivan commends Nucleus Security for setting a high standard in competitive strategy, execution, and market responsiveness. The company's strategic vision, advanced integration capabilities, and dedication to delivering integrated, contextual, and actionable intelligence are shaping the future of vulnerability and exposure management and helping organizations achieve real, measurable risk reduction at scale. Each year, Frost & Sullivan presents the Transformational Innovation Leadership Recognition to a company that demonstrates outstanding strategy development and implementation, resulting in measurable improvements in innovation, customer satisfaction, and market influence. This recognition highlights companies driving meaningful change and accelerating category evolution through technology and strategic excellence. Frost & Sullivan Best Practices Recognition Frost & Sullivan's Best Practices Recognitions honor companies across regional and global markets that exhibit exceptional achievement and consistent excellence in areas such as leadership, technological innovation, customer experience, and strategic product development. Each recognition is the result of a rigorous analytical process in which Frost & Sullivan industry experts benchmark performance through comprehensive interviews, deep-dive analysis, and extensive secondary research. The goal is to identify true best-in-class organizations that are driving transformative growth and setting new industry standards.Contact us: Start the discussion. Contact Camila TinajeroE: camila.tinajero@frost.com  About Nucleus Security Nucleus Security is the enterprise leader in unified vulnerability and exposure management, enabling organizations to prioritize and mitigate vulnerabilities faster, at scale. Delivering unmatched time to value, Nucleus automatically unifies and organizes data from all your security and business tools into a single pane of glass. With powerful dynamic automations, teams can effectively automate their vulnerability management program. As a FedRAMP authorized vendor, Nucleus Security is transforming how enterprises, federal agencies and defense contractors secure their digital assets and networks. For more information about Nucleus Security and its services, please visit: https://nucleussec.com/

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 129 加入收藏 :
Aon Joins Ferrari Hypersail as Premium Partner

Aon Expands Ferrari Partnership into High-Performance Sailing, Promoting Innovation and Resilience MILAN, Feb. 17, 2026 /PRNewswire/ -- Aon plc (NYSE: AON), a leading global professional services firm, today announced that it will serve as the Premium Partner of Ferrari Hypersail, an unprecedented marine initiative dedicated to high-performance sailing. In 2025, Aon became an Official Partner of the Scuderia Ferrari HP Formula One team through a multi-year agreement. By extending their relationship from the racetrack to the water, Aon aims to demonstrate how resilience and better decision-making can unlock new possibilities for clients and set new standards in competitive sport. This partnership will come to life through brand applications across the boat, crew uniforms and global event integrations. "We're excited to join Ferrari on this innovative journey into offshore sailing," said Carlo Clavarino, executive chairman of international business for Aon. "Ocean racing is all about making smart, real-time decisions in the face of uncertainty. By combining our data‑driven insights with Ferrari's engineering excellence, we're charting new paths in engineering and risk management. It's a fantastic opportunity to work together and drive real innovation." Developed to explore new frontiers of innovation, self-sufficiency and performance in ocean racing, this 30-meter monohull prototype combines advanced engineering with a design focused on stability, using three points of contact. The boat generates all of its own power while underway and is powered entirely by renewable energy. Its key innovation is the integration of a canting keel equipped with a foil which acts as a support point during flight, supported by a rudder and two lateral foils. The initiative is led by Giovanni Soldini, a world-renowned sailing pioneer and Team Principal, whose long-standing collaboration with Aon brings deep expertise to this new venture. Currently under construction in Italy, the boat is set to launch in 2026, with sea trials commencing shortly afterward. "We are very proud to stand alongside Ferrari in this innovative project. With Ferrari Hypersail, we are taking a step further: thanks to the strength of the Ferrari brand and the international dimension of the project, we are broadening our reach and bringing the story of innovation, sustainability and risk management to an even wider audience made up of all size companies, sports enthusiasts, innovators and new generations," said Andrea Parisi, CEO of Italy and Eastern Mediterranean for Aon. "Partnering with Ferrari — on the racetrack and now on the water — provides Aon with a unique opportunity to engage our clients in new and meaningful ways, bringing them closer to innovation and the spirit of exploration." "Hypersail represents a new platform for Ferrari to develop meaningful partnerships that extend beyond visibility and are rooted in shared values and expertise," said Lorenzo Giorgetti, Chief Racing Revenues Officer of Ferrari. "Aon is a natural partner for a project of this scale, taking an active role at the heart of the initiative and helping shape a living ecosystem where performance and risk management are essential elements." "Ferrari Hypersail is a project with an exceptionally high level of research and innovation, exploring completely unprecedented scenarios," said Antonio Picca Piccon, CFO of Ferrari. "Having Aon onboard as a partner represents a significant added value, thanks to its strong expertise in risk management and its previous experience in ocean racing." About AonAon plc (NYSE: AON) exists to shape decisions for the better — to protect and enrich the lives of people around the world. Through actionable analytic insight, globally integrated Risk Capital and Human Capital expertise, and locally relevant solutions, our colleagues provide clients in over 120 countries with the clarity and confidence to make better risk and people decisions that protect and grow their businesses. Follow Aon on LinkedIn, X, Facebook and Instagram. Stay up-to-date by visiting Aon's Newsroom and sign up for news alerts here. Aon Media Contactmediainquiries@aon.comToll-free (U.S., Canada and Puerto Rico): +1 833 751 8114International: +1 312 381 3024 Aon plc (NYSE: AON) exists to shape decisions for the better — to protect and enrich the lives of people around the world. Through actionable analytic insight, globally integrated Risk Capital and Human Capital expertise, and locally relevant solutions, our colleagues in over 120 countries provide our clients with the clarity and confidence to make better risk and people decisions that protect and grow their businesses. Follow Aon on LinkedIn, X, Facebook and Instagram. Stay up-to-date by visiting Aon’s newsroom and sign up for news alerts here.  

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 170 加入收藏 :
2026 年 3 月 9 日 (星期一) 農曆正月廿一日
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