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ROSEN, A TOP RANKED LAW FIRM, Encourages Tandem Diabetes Care, Inc. Investors to Inquire About Securities Class Action Investigation - TNDM
TMX Newsfile· 2026-02-03 20:00
Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Tandem Diabetes Care, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Company Information - Tandem Diabetes Care, Inc. is facing scrutiny after a press release on August 7, 2025, announced a voluntary medical device correction for select t:slim X2 insulin pumps, which could lead to a discontinuation of insulin delivery due to a speaker-related issue [3]. - Following the announcement, Tandem Diabetes' stock experienced a significant decline of 19.9% on the same day [3]. Group 2: Legal Actions - Investors who purchased Tandem Diabetes securities may be eligible for compensation through a class action lawsuit being prepared by Rosen Law Firm, which operates on a contingency fee basis [2]. - The firm emphasizes the importance of selecting qualified legal counsel with a proven track record in securities class actions, highlighting its own success in recovering substantial amounts for investors [4]. Group 3: Firm's Credentials - Rosen Law Firm has achieved notable recognition, including the largest securities class action settlement against a Chinese company and being ranked No. 1 for securities class action settlements in 2017 [4]. - The firm has consistently ranked in the top 4 for securities class action settlements since 2013 and has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4].
GEHC Wins FDA Clearance & CE Mark for Allia Moveo, Marks Global Debut
ZACKS· 2026-02-03 19:16
Key Takeaways GEHC secures FDA 510(k) clearance and CE Mark for Allia Moveo, enabling commercialization.Allia Moveo's compact, cable-free design and AI-enabled guidance aim to boost workflow efficiency.GEHC reports first global installation in France and initial U.S. deployment, supporting vascular procedures.GE HealthCare Technologies Inc. (GEHC) recently announced that it has obtained FDA 510(k) clearance and CE Marking for its Allia Moveo, enabling commercialization of its latest interventional imaging p ...
Investor Notice: Shareholder Rights Law Firm Robbins LLP Informs Investors of the Picard Medical, Inc. Securities Class Action Lawsuit
Businesswire· 2026-02-03 17:58
Core Viewpoint - Robbins LLP has announced a class action lawsuit against Picard Medical, Inc. for alleged fraudulent stock promotion activities that misled investors [1] Group 1: Allegations Against Picard Medical, Inc. - The lawsuit claims that Picard Medical was involved in a fraudulent stock promotion scheme that utilized social media misinformation and impersonated financial professionals [1] - It is alleged that insiders and/or affiliates used offshore or nominee accounts to facilitate the coordinated dumping of shares during a price inflation campaign [1] - The company's public statements and risk disclosures reportedly omitted any mention of false rumors and artificial trading activity that influenced the stock price [1] Group 2: Stock Price Impact - On October 24, 2025, Picard Medical's stock price fell sharply by 70%, dropping to $3.99 per share [1] - Following the initial crash, the stock price has continued to decline, reaching approximately $2.00 per share [1] Group 3: Class Action Participation - Investors who purchased Picard Medical securities between September 2, 2025, and October 31, 2025, may be eligible to participate in the class action [1] - Shareholders wishing to serve as lead plaintiff must file their papers with the court by April 3, 2026 [1] - Participation in the case is not required to be eligible for recovery, allowing investors to remain absent class members if they choose [1]
Zimmer Biomet to Report Q4 Earnings: Here's What to Expect
ZACKS· 2026-02-03 17:40
Core Viewpoint - Zimmer Biomet Holdings, Inc. (ZBH) is set to report its fourth-quarter 2025 results on February 10, with expectations of revenue growth and earnings per share (EPS) increase compared to the previous year [1][9]. Group 1: Financial Estimates - The Zacks Consensus Estimate for ZBH's revenues is $2.20 billion, reflecting an 8.9% increase from the same quarter last year [2]. - The consensus estimate for earnings is $2.38 per share, indicating a 3% rise from the year-ago figure [2]. - The bottom-line estimate has remained unchanged over the past 30 days [2]. Group 2: Business Segment Performance - The Hips business is expected to grow due to the company's comprehensive solutions, including the new Z1 triple-taper hip system and the automated HAMMR surgical impactor [3][4]. - The total Hips business is projected to report a 10.5% year-over-year growth [5]. - The Knees business is likely to benefit from the increasing adoption of the Persona OsseoTi cementless total knee system, with an expected 7.5% year-over-year growth [6]. - The S.E.T business is anticipated to continue its growth trend, with expectations of mid-single-digit growth for the seventh consecutive quarter [7]. - New product launches in the foot and ankle trauma portfolio, such as the Gorilla Pilon Fusion Plating system, may positively impact fourth-quarter performance [8]. Group 3: Recent Developments - Zimmer Biomet received PMDA approval in Japan for its iTaperloc Complete and iG7 Hip System, which may enhance top-line performance [5]. - The acquisition of Paragon 28, Inc. and the CE Mark certification for the RibFix Advantage Fixation System are expected to contribute positively to the company's performance [10]. - The company completed the acquisition of Monogram Technologies Inc., an AI-driven orthopedic robotics firm, which may also have a favorable impact on fourth-quarter results [12]. Group 4: Growth Projections - The Technology & Data, Bone Cement, and Surgical business is estimated to report a 6.5% year-over-year growth for the quarter [13]. - The total S.E.T. business is projected to achieve a 13% year-over-year growth [10].
CLASS ACTION DEADLINE APPROACHING: Berger Montague Advises Integer Holdings Corporation (ITGR) Investors to Inquire About a Securities Fraud Class Action by February 9, 2026
TMX Newsfile· 2026-02-03 16:38
Core Viewpoint - A class action lawsuit has been filed against Integer Holdings Corporation for allegedly making misleading statements and failing to disclose material adverse facts regarding its business performance during the specified Class Period [1][3]. Group 1: Lawsuit Details - The lawsuit is on behalf of investors who acquired Integer securities from July 25, 2024, to October 22, 2025 [1][2]. - Investors have until February 9, 2026, to seek appointment as lead plaintiff representatives [2]. Group 2: Allegations Against the Company - The complaint alleges that Integer overstated its competitive position and did not adequately disclose a deterioration in sales of its electrophysiology devices [3]. - The lawsuit claims that the company mischaracterized its growth drivers [3]. Group 3: Impact of Disclosures - The truth about the company's performance began to emerge on October 23, 2025, when Integer reduced its sales guidance and disclosed an expected sales decline [3]. - Following these disclosures, Integer's stock price fell by $35.22 per share, a decline of over 32% in one trading day [3].
Inspira Technologies Validates Next-Gen Standalone HYLA™ Blood Sensor with Clinical-Grade Accuracy, Targeting $48 Billion Heart-Lung Surgery Market
Globenewswire· 2026-02-03 14:22
Core Insights - Inspira Technologies has successfully validated its Next-Generation Standalone HYLA™ System, which is designed to operate independently of its existing respiratory support devices, allowing entry into the $50 billion heart-lung surgery market upon clearance [1][4] Group 1: Product Validation and Performance - The HYLA™ optical sensor achieved a 94.2% accuracy in tracking the Partial Pressure of Carbon Dioxide (pCO₂), aligning with clinical needs and demonstrating concordance with gold-standard blood gas analyzers within a 7 mmHg threshold [2][3] - This system provides continuous, non-invasive monitoring of a patient's metabolic status, potentially reducing complications during heart-lung machine and ECMO procedures by eliminating the need for intermittent blood draws [2][3] Group 2: Strategic Market Positioning - By decoupling the HYLA™ sensor from existing life-support hardware, Inspira Technologies is advancing a standalone system that can integrate into any operating room or ICU workflow, significantly expanding its total addressable market [3] - The company is pursuing a high-margin, recurring revenue model through the sale of disposable optical sensors and modular software upgrades, enhancing its long-term growth prospects [3][4] Group 3: Future Plans and Industry Engagement - The CEO of Inspira Technologies indicated that the validation confirms the technology operates at a clinical grade, enabling faster market entry and serving a large global installed base of perfusion systems [4] - The company is moving towards a planned FDA regulatory submission process in 2026, focusing on extracorporeal procedures as an immediate commercial opportunity [4]
Medical device maker Medtronic to buy CathWorks in up to $585 million deal
Reuters· 2026-02-03 14:06
Core Viewpoint - Medtronic is acquiring CathWorks for up to $585 million to enhance its heart devices portfolio with a new diagnostic tool [1] Group 1: Acquisition Details - The deal is valued at up to $585 million, indicating a significant investment by Medtronic in expanding its capabilities in the heart device market [1] - CathWorks is a privately held company, suggesting that this acquisition may provide Medtronic with innovative technologies that are not yet widely available in the market [1] Group 2: Strategic Implications - This acquisition aligns with Medtronic's strategy to bolster its offerings in the cardiovascular sector, which is a critical area of growth for the company [1] - The addition of CathWorks' diagnostic tool could potentially improve patient outcomes and enhance the overall effectiveness of heart disease management [1]
DuPont Launches Liveo™ C6-8XX Liquid Silicone Rubber Series for Healthcare Applications
Prnewswire· 2026-02-03 14:00
Core Insights - DuPont has launched the Liveo C6-8XX Liquid Silicone Rubber (LSR), a new series of medical-grade silicone elastomers designed to meet stringent medical device application requirements [1][4]. Group 1: Product Features - The Liveo C6-8XX LSR series offers improved rheology and lower viscosity, enabling faster and more consistent molding cycles, making it suitable for fully automated production environments [2][4]. - The series includes five products with hardness ranging from 30 to 70 Shore A: Liveo C6-830 LSR, Liveo C6-840 LSR, Liveo C6-850 LSR, Liveo C6-860 LSR, and Liveo C6-870 LSR [3]. Group 2: Compliance and Quality - The new LSR series meets USP Class VI and select EP regulatory requirements, complies with REACH SVHC (< 0.1% w/w) requirements, and has been tested according to ISO 10993 standards [4]. - Liveo C6-8XX LSRs are manufactured under ISO 9001, 14001, and 13485 certifications, ensuring high quality and reliability for healthcare applications [4]. Group 3: Market Positioning - The product is designed to provide flexibility and reliability for medical device manufacturers, with a pot life of over three days, allowing for improved processability and complex designs [4]. - Supplied in two-component kits, the Liveo C6-8XX LSR materials complement precision molding and automated systems, helping OEMs achieve efficiency without compromising safety or performance [5].
Ocumetics Reports Positive Three Month First-in-Human Results, Significantly De-Risking Its Accommodating Intraocular Lens Technology
Thenewswire· 2026-02-03 13:50
Core Insights - Ocumetics Technology Corp. announced positive three-month postoperative results from Group 1 patients in its first-in-human clinical study of the Ocumetics Accommodating Intraocular Lens, validating the company's core technology and marking a significant clinical de-risking milestone as it progresses to subsequent study phases [2][6]. Clinical Results - Group 1 data met or exceeded all predefined internal benchmarks for safety, lens delivery, and foundational distance visual performance, successfully achieving the primary objectives required to advance the clinical program [3][6]. - Patients in Group 1 entered the study with severe visual impairment, with some presenting uncorrected preoperative acuities as poor as 20/250, and post-implantation outcomes demonstrated significant improvements in everyday vision [4][5]. Management Statements - The President and CEO of Ocumetics expressed confidence in the accommodating intraocular lens technology following the successful results, indicating that planning for Group 2 surgeries has already begun [4][10]. - The principal investigator of the trial highlighted that all patient outcomes met safety expectations and emphasized the life-changing impact of the implantations on patients previously classified as legally blind [5][7]. Future Developments - Ocumetics is applying a rapid "win-learn" R&D approach, incorporating real-time surgeon feedback to optimize performance, with refinements to the lens delivery mechanism already implemented based on insights from Group 1 [8]. - Manufacturing and testing of optimized lens designs are currently underway, with Group 2 surgeries expected to be scheduled following the completion of final lens testing and validation [9].
Allergan Aesthetics Continues Its Mission of Empowering Women Through the Faces of Natrelle® Testimonial Program
Prnewswire· 2026-02-03 13:50
Core Insights - Allergan Aesthetics, a subsidiary of AbbVie, has launched the Faces of Natrelle Testimonial Program to encourage women to share their experiences with Natrelle breast implants, aiming to educate and empower others considering breast surgery [1][2][6] Group 1: Program Overview - The Faces of Natrelle initiative invites women aged 22 and older who have undergone breast augmentation or reconstruction to submit testimonials, photos, or videos to be featured on various platforms [2][3] - The program aims to address misconceptions surrounding breast procedures and promote transparency and empowerment among women [2][3] Group 2: Participant Incentives - Participants who share their experiences may be eligible to receive $500 in All Gift Cards if their content is approved, while reconstruction patients are encouraged to share their stories without compensation [4][8] - The program emphasizes the importance of sharing personal journeys to provide clarity and confidence to others [3][6] Group 3: Company Background - Allergan Aesthetics develops and markets a range of aesthetic products, including breast implants, and is committed to innovation and education in the aesthetics field [19] - AbbVie, the parent company, focuses on delivering innovative medicines and solutions across various therapeutic areas, including aesthetics [20]