Acquisition - Hologic entered into an agreement to be acquired by Blackstone and TPG for $76 per share in cash plus a contingent value right of up to $3 per share, potentially reaching $79 per share[13] - The acquisition is expected to close in the first half of calendar year 2026[13] Financial Performance - Hologic's Q4'25 GAAP revenue was $1,049.5 million, a 6.2% increase compared to Q4'24[68] - Q4'25 Non-GAAP revenue was also $1,049.5 million, with organic revenue at $1,027.7 million and organic revenue excluding COVID at $998.6 million[69] - Hologic's GAAP diluted EPS for Q4'25 was $0.83, a 9.2% increase[68] - Non-GAAP diluted EPS for Q4'25 was $1.13, an 11.9% increase[69] - The company's net debt to adjusted EBITDA leverage ratio is 0.4x[59, 111] Segment Performance - Diagnostics revenue in Q4'25 was $454.1 million[70] - Breast Health revenue in Q4'25 was $393.7 million[70] - GYN Surgical revenue in Q4'25 was $172.5 million[70] - Skeletal Health revenue in Q4'25 was $29.2 million, a 128.1% increase[70]

Group 1 - The article does not provide any specific content related to a company or industry [1]

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Baxter International Inc. due to allegations of federal securities law violations related to the Novum LVP device malfunctions, which have reportedly caused serious risks to patients [2][4]. Group 1: Allegations and Impact - The complaint alleges that Baxter and its executives made false or misleading statements regarding the Novum LVP, failing to disclose systemic defects that led to malfunctions, including underinfusion and overinfusion, posing risks of serious injury or death to patients [4]. - Baxter was reportedly aware of multiple device malfunctions, injuries, and deaths but did not take adequate remedial measures, leading to a heightened risk of customers removing the Novum LVPs from service and pausing new sales [4]. - Following the announcement on July 31, 2025, regarding the voluntary pause of shipments and installations of the Novum LVP, Baxter's stock price fell by 22.4%, closing at $21.76 [5]. Group 2: Legal Proceedings - Investors who suffered losses exceeding $100,000 in Baxter between February 23, 2022, and July 30, 2025, are encouraged to contact Faruqi & Faruqi to discuss their legal rights and options [1][2]. - The deadline for investors to seek the role of lead plaintiff in the federal securities class action against Baxter is December 15, 2025 [2][6]. - Faruqi & Faruqi is also inviting anyone with information regarding Baxter's conduct, including whistleblowers and former employees, to come forward [6].

Core Insights - Merit Medical Systems, Inc. announced 24-month efficacy findings from the non-randomized AVG cohort of the WAVE trial, showcasing the performance of the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE) for patients with advanced kidney disease undergoing hemodialysis [1][5][6] Group 1: Trial Overview - The WAVE trial aimed to evaluate the performance of the WRAPSODY CIE in restoring functional vascular access in patients with complications such as stenosis or occlusion [3] - The trial involved 43 centers across the United States, South America, and the United Kingdom [3] Group 2: Efficacy Results - In the non-randomized arm of the WAVE trial, 112 patients were treated with the WRAPSODY CIE, achieving a target lesion primary patency (TLPP) of 81.4% at 6 months, exceeding the established performance goal of 60% [4] - The TLPP at 12 months was 60.2%, and at 24 months, it was 41.7% [4][10] - The access circuit primary patency (ACPP) at 12 months was 36.2%, and at 24 months, it was 25.7% [4][10] Group 3: Regulatory Approvals - The WRAPSODY CIE received premarket approval from the US FDA on December 19, 2024, and was approved by Health Canada on April 30, 2025 [6] - The device has also received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil [6] Group 4: Future Research - Real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America Registry, which aims to enroll up to 250 patients [8]

（原标题：被纳入医保的脑机接口，我们什么时候能用上？） 20世纪70年代， 个人计算机才刚刚诞生， 但事实真的是这样吗？ 其实，我们与脑机接口的距离比想象的要近。 今年9月， 浙江省医保局正式将"非侵入式脑机接口适配费"纳入基本医保。 脑机接口的概念就已经被提起。 可到了2025年， 个人计算机早已走进千家万户， 脑机接口却好像依旧属于科幻小说。 为什么这项技术还未彻底普及应用， 就已经开始加入医保了？ 虽然脑机接口还未走入生活， 但已经展现出足够的潜力。 全球的前沿企业， 都在推动脑机接口在临床上的应用。 美国脑机接口公司Synchron， 使瘫痪患者可以通过脑信号控制外部设备。 马斯克频繁宣传其公司Neuralink的潜力， 声称未来脑机接口有望实现意识上传和思维控制等功能。 中国的脑机接口技术， 也在蓬勃发展。 2025年3月，中国完成首例侵入式脑机接口临床试验， 一名四肢截肢的患者通过植入设备， 经过训练后用意念即可玩游戏。 2025年9月，南方医科大学珠江医院完成华南首例脑机接口治疗癫痫手术， 通过24小时监测脑电活动， 在发作前精准阻击癫痫。 中国脑机接口市场规模逐年提升， 2024年已达32亿元 ...

CONTACT US HERE:https://securitiesclasslaw.com/securities/baxter-international-inc-loss-submission-form- 2/?id=174900&from=4 CLASS PERIOD: February 23, 2022 to July 30, 2025 ALLEGATIONS: The complaint alleges that during the class period, Defendants issued materially false and/or misleading statements and/or failed to disclose that: (a) Baxter's recently launched product, the Novum LVP, suffered systemic defects that caused widespread malfunctions, including underinfusion, overinfusion, and complete non-del ...

Core Insights - The manufacturing line for the Pivot Controller has been validated for human-use production, supporting an expected market launch in Q1 2026 [1] - Pivot aims to introduce the first two-part tubeless patch pump, targeting the $3 billion market for adult "almost-pumpers" with a design that is affordable, user-friendly, and easy to learn [1]

Core Insights - Iradimed Corporation reported record revenue of $21.2 million for Q3 2025, marking a 16% increase year-over-year, and maintained a strong gross margin of 78% [2][6][8] - The company is set to begin limited commercial shipments of its next-generation 3870 MRI-compatible IV infusion pump in December 2025, with full commercialization expected in Q1 2026 [3][4] - For Q4 2025, the company anticipates revenue between $21.4 million and $22.4 million, and has raised its full-year revenue guidance to $82.5 million to $83.5 million [4][16] Financial Performance - For the three months ended September 30, 2025, the company reported net income of $5.6 million, an increase of 10% from $5.0 million in Q3 2024, translating to diluted earnings per share of $0.43, up 8% from $0.40 [6][8] - Non-GAAP net income for Q3 2025 was $6.1 million, a 10% increase from $5.5 million in the same period of 2024, with non-GAAP diluted earnings per share at $0.47, up 9% [7][10] - For the nine months ended September 30, 2025, revenue reached $61.1 million, a 13% increase from $53.9 million in the same period of 2024, with net income also increasing by 13% to $16.0 million [9][10] Operational Highlights - The company completed the construction of its new facility in Orlando, Florida, with total costs amounting to approximately $13.3 million, and the facility is now fully operational [15] - The backlog for the company's pump and monitor products is at an all-time high, indicating strong demand [2][3] - Domestic sales accounted for 85% of total revenue for both Q3 and the nine months ended September 30, 2025, compared to 83% and 82% respectively in the prior year [11][12] Dividend Information - The board of directors declared a regular quarterly cash dividend of $0.17 per share, payable on November 25, 2025, to stockholders of record as of November 14, 2025 [5][8]

Core Insights - AVITA Medical's RECELL System is positioned as a standard of care for acute wound treatment, demonstrating significant clinical and economic benefits across various wound types and patient populations [1][3][5] Clinical Evidence - A systematic review of 99 peer-reviewed studies involving over 8,000 patients across 13 countries confirms that the RECELL System consistently delivers strong outcomes, achieving wound closure with less donor skin and faster healing [3][4] - The RECELL System reduces donor site burden by up to 97.55% and meets or exceeds outcomes observed with traditional split-thickness skin grafts (STSG) [7] Economic Impact - Real-world data from the American Burn Association's registry shows that RECELL treatment results in a 36% average reduction in hospital stays, equating to a 5.6-day decrease [4][8] - The estimated cost savings per patient treated with RECELL is over $42,000, allowing hospitals to treat an additional 13 patients per bed annually [8] Patient Outcomes - RECELL treatment leads to improved patient recovery, with 83% of patients discharged home compared to 70% for STSG [8] - The findings highlight the ability of RECELL to accelerate recovery and enhance resource utilization in healthcare settings [5][8]

Core Insights - InMode Ltd. has appointed Michael Dennison as President of North America, highlighting his extensive experience in the aesthetic medical device industry and his previous leadership roles within the company [1][2]. Company Overview - InMode is a leading global provider of innovative medical technologies, specializing in devices that utilize novel radiofrequency (RF) technology for various medical applications, including plastic surgery, gynecology, dermatology, otolaryngology, and ophthalmology [3]. Leadership and Strategy - Michael Dennison's promotion is seen as a strategic move to enhance InMode's market presence and drive growth in North America, with a focus on cultivating talent and achieving market excellence [2]. - Dennison aims to build on InMode's strong foundation and accelerate momentum in the North American market, delivering greater value to partners and setting new industry standards [2]. Financial Performance - InMode expects to report third-quarter 2025 revenue between $92.5 million and $93.0 million, reiterating its full-year 2025 guidance of $365 million to $375 million [5].