Key Takeaways CeriBell gained FDA clearance for its continuous EEG-based delirium monitoring solution.The system delivers real-time EEG insights to cut clinical variability and aid earlier delirium detection.Tested on 225 adults, the algorithm builds on prior Breakthrough status and ties to a CMS NTAP bid.CeriBell Inc. (CBLL) recently announced that the FDA has given 510(k) clearance for its latest delirium monitoring solution, making it the one and only FDA-cleared solution for continuous tracking of delir ...

Core Viewpoint - The complaint against Baxter International alleges violations of federal securities laws due to misleading statements regarding the Novum LVP, which suffered systemic defects leading to serious patient risks [2]. Group 1: Allegations and Defects - The Novum LVP experienced systemic defects causing malfunctions such as underinfusion, overinfusion, and non-delivery of fluids, posing risks of serious injury or death to patients [2]. - Baxter was aware of multiple device malfunctions, injuries, and deaths related to these defects but failed to adequately address them [2]. - The company's attempts to remedy the situation through customer alerts were deemed insufficient as design flaws persisted, continuing to harm patients [2]. Group 2: Impact on Business Operations - Due to the defects, there was an increased risk that customers would be instructed to take existing Novum LVPs out of service, and Baxter would halt all new sales of these pumps [2]. - Baxter's statements regarding the safety, efficacy, product rollout, customer feedback, and sales prospects of the Novum LVPs were materially false and misleading [2]. Group 3: Market Reaction - The extent of the alleged fraud was revealed on July 31, 2025, when Baxter announced a voluntary and temporary pause in shipments and installations of the Novum LVP, leading to a 22.4% drop in stock price, closing at $21.76 on the same day [3].

Core Insights - Zacks Premium offers tools for investors to enhance their stock market strategies and confidence [1] - The Zacks Style Scores are designed to complement the Zacks Rank, helping investors identify stocks likely to outperform the market [2] Zacks Style Scores Overview - Stocks are rated A, B, C, D, or F based on value, growth, and momentum characteristics, with higher scores indicating better performance potential [3] - The Value Score focuses on identifying undervalued stocks using financial ratios like P/E and Price/Sales [4] - The Growth Score assesses a company's financial health and future growth potential through earnings and sales projections [5] - The Momentum Score identifies stocks with favorable price trends, utilizing recent price changes and earnings estimate shifts [6] - The VGM Score combines all three Style Scores, providing a comprehensive indicator for stock selection [6] Zacks Rank and Style Scores Interaction - The Zacks Rank uses earnings estimate revisions to identify top-performing stocks, with 1 (Strong Buy) stocks achieving an average annual return of +23.81% since 1988 [7] - There are over 800 stocks rated 1 or 2, making it essential to use Style Scores for effective selection [8] - Stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B are recommended for maximizing return potential [9] Company Spotlight: The Cooper Companies - The Cooper Companies operates in the medical device sector with two segments: CooperVision (CVI) and CooperSurgical (CSI) [11] - CVI specializes in contact lenses, particularly in daily silicone hydrogel lenses and myopia management, while CSI focuses on fertility and women's health products [11] - COO holds a 2 (Buy) rating on the Zacks Rank, with a VGM Score of B and a Momentum Style Score of A, reflecting a 14.4% increase in share price over the past four weeks [12] - Recent upward revisions in earnings estimates indicate a positive outlook, with the Zacks Consensus Estimate rising to $4.47 per share [12] - COO's strong performance metrics make it a notable investment opportunity [13]

Core Viewpoint - Abbott has announced a 6.8% increase in its quarterly common dividend to 63 cents per share, marking its 54th consecutive year of dividend growth and the 408th consecutive quarterly dividend payment since 1924 [1][4]. Group 1: Dividend Information - The quarterly dividend payout has increased more than 70% since 2020 [1][4]. - The cash dividend is payable on February 13, 2026, to shareholders of record as of January 15, 2026 [1]. Group 2: Company Background - Abbott is a global healthcare leader with a diverse portfolio in diagnostics, medical devices, nutritionals, and branded generic medicines, serving over 160 countries [3]. - Abbott is a member of the S&P 500 Dividend Aristocrats Index, which includes companies that have increased dividends annually for at least 25 consecutive years [2].

Core Viewpoint - A securities class action lawsuit has been filed against Inspire Medical Systems, Inc. (NYSE: INSP) for allegedly misleading investors about operational failures related to the launch of its Inspire V device for obstructive sleep apnea [1][3]. Group 1: Allegations and Impact - The lawsuit claims that Inspire Medical assured investors of its "operational readiness" for the Inspire V launch, which was later revealed to be false due to undisclosed operational issues [3][4]. - Key operational failures included delays in Medicare claims processing software updates, which did not take effect until July 1, 2025, preventing implanting centers from billing for procedures [4]. - An excess inventory of the older Inspire IV device created a channel glut, negatively impacting demand for the new Inspire V product and leading to a significant cut in 2025 earnings per share (EPS) guidance by over 80% [4]. - Many treatment centers had not completed necessary training and onboarding for the new device, contributing to a $42.04 per share drop in stock value, equating to a 32.4% decline [4]. Group 2: Legal Actions and Investor Guidance - Investors who purchased Inspire Medical securities between August 6, 2024, and August 4, 2025, are encouraged to contact Hagens Berman to discuss their legal rights before the Lead Plaintiff Deadline of January 5, 2026 [2][3]. - Hagens Berman is focusing on the concealment of critical operational issues, emphasizing the impact of management's narrative on the stock's performance [5]. - Whistleblowers with non-public information regarding Inspire are encouraged to assist in the investigation, with potential rewards under the SEC Whistleblower program [6].

Core Viewpoint - Tandem Diabetes Care is facing significant challenges, with a 43% decline in share price, and while it has innovative products, it needs to achieve consistent revenue growth to become an attractive investment [2][6]. Company Overview - Tandem Diabetes Care is a medical device company known for its innovative insulin pumps, particularly the t:slim X2, which has been a key growth driver [4]. - The company launched the Tandem Mobi, a smaller device that can be controlled via a smartphone app, in the U.S. last year [5]. Financial Performance - Despite its innovative offerings, Tandem Diabetes Care has experienced declining revenue growth over the past five years due to competition and lower demand for insulin pumps [5]. - The company remains unprofitable, and the current global trade environment may worsen its financial situation, particularly due to reliance on imported parts from countries like Mexico and China [6][8]. - The market capitalization of Tandem Diabetes Care is approximately $1 billion, with a gross margin of 53.23% [8]. Growth Potential - For Tandem Diabetes Care to be considered a viable investment, it needs to achieve mid-to-high teens revenue growth by expanding market share and encouraging current users to upgrade their devices [9]. - The introduction of the Tandem Mobi and other products in development could contribute to this growth strategy [10]. Investment Outlook - Currently, the stock is not recommended for purchase due to inconsistent revenue growth, competitive pressures, and industry challenges that may hinder profitability [10].

Core Viewpoint - A class action securities lawsuit has been filed against Inspire Medical Systems, Inc. due to alleged securities fraud affecting investors between August 6, 2024, and August 4, 2025 [1] Group 1: Lawsuit Details - The lawsuit claims that the launch of Inspire Medical's new product, Inspire V, was unsuccessful due to poor demand and excess inventory at treatment centers, contradicting the company's assurances of a successful launch [2] - Allegations include that Inspire Medical failed to complete essential tasks for the product launch, such as training for treatment center customers, setting up IT systems, and ensuring Medicare reimbursement was in place [2] Group 2: Investor Information - Investors who suffered losses during the specified timeframe have until January 5, 2026, to request appointment as lead plaintiff, although participation in any recovery does not require serving as lead plaintiff [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing significant settlements for shareholders and is recognized as one of the top securities litigation firms in the United States [4]

Core Viewpoint - Inspire Medical Systems, Inc. is facing a class action lawsuit for securities fraud following a significant drop in stock price due to alleged violations of federal securities laws [1][3]. Group 1: Lawsuit Details - A class action lawsuit has been filed against Inspire Medical Systems and certain senior executives, with investors encouraged to contact BFA Law by January 5, 2026, to lead the case [1][3]. - The lawsuit claims violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and is pending in the U.S. District Court for the District of Minnesota [3]. Group 2: Company Background - Inspire Medical Systems develops and manufactures an implantable medical device for treating sleep apnea, with the latest version being Inspire V, which received FDA approval on August 2, 2024 [4]. Group 3: Stock Performance and Issues - Inspire assured investors that it had taken necessary steps for the launch of Inspire V, but failed to prepare clinicians and payors, leading to delays in adoption and weak demand due to excess inventory of older devices [5][6]. - On August 4, 2025, Inspire disclosed an "elongated timeframe" for the Inspire V launch and reduced its 2025 earnings per share guidance by over 80%, attributing this to undisclosed factors including incomplete training at implanting centers and poor demand [7]. - Following this announcement, Inspire's stock price dropped by $42.04 per share, or more than 32%, from $129.95 on August 4, 2025, to $87.91 on August 5, 2025 [8].

Core Viewpoint - A class action lawsuit has been filed against Integer Holdings Corporation and its senior executives for securities fraud following a significant drop in stock price due to alleged violations of federal securities laws [2][4]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Southern District of New York, titled West Palm Beach Firefighters' Pension Fund v. Integer Holdings Corporation, et al., No. 1:25-cv-10251 [4]. - Investors have until February 9, 2026, to request to lead the case [4]. Group 2: Company Performance and Allegations - Integer designs and manufactures cardiac rhythm management and cardiovascular products, including electrophysiology devices [5]. - The company allegedly overstated demand for its electrophysiology devices while public assurances contradicted the actual decline in demand and revenue [6][5]. Group 3: Stock Price Impact - On October 23, 2025, Integer lowered its 2025 sales guidance to between $1.840 billion and $1.854 billion, down from $1.850 billion to $1.876 billion, which was below analysts' expectations [7]. - The company projected poor net sales growth of -2% to 2% and organic sales growth of 0% to 4% for 2026, admitting that two of its EP devices had slower than expected adoption [7]. - Following this announcement, Integer's stock price fell by $35.22 per share, a decrease of over 32%, from $109.11 on October 22, 2025, to $73.89 on October 23, 2025 [7].

Core Insights - NanoVibronix, Inc. will change its corporate name to ENvue Medical, Inc. effective December 12, 2025, to align with its strategic focus on the ENvue® feeding-tube placement system [1] - The company's stock ticker will change to "FEED" on the same date, with no action required from current stockholders [2] Company Strategy - The company aims to scale hospital utilization, enhance its commercial presence, and develop a comprehensive enteral-feeding ecosystem around ENvue through both internal and external opportunities [2] - The rebranding signifies a new phase characterized by precision enteral access, technology-driven growth, and clinical excellence [2] Company Overview - NanoVibronix, Inc. specializes in non-invasive and minimally invasive medical technology solutions, with headquarters in Tyler, Texas, and R&D in Nesher, Israel [3] - The company focuses on advancing standards in non-invasive therapy and minimally invasive navigation, emphasizing patient safety, clinical usability, and technological innovation [3] Product Information - The ENvue Navigation Platform is a minimally invasive electromagnetic navigation system designed to assist clinicians in placing feeding tubes, providing real-time visualization during the procedure [5] - The platform is FDA 510(k) cleared for adult use and may expand to include pediatric and vascular access applications in the future [5]