Company Overview - Outset Medical Inc. is a medical technology company based in San Jose, California, known for developing and producing the Tablo Hemodialysis System [3]. Allegations and Financial Performance - On November 10, 2025, Outset Medical reported its third-quarter 2025 financial results, showing non-GAAP earnings per share of –$0.69, which missed consensus estimates by $0.03. The revenue was reported at $29.43 million, falling short of expectations by $1.27 million [4]. - The company also revised its full-year 2025 revenue guidance down to a range of $115–$120 million from the previous range of $122–$126 million, citing delays in several anticipated opportunities [4]. Stock Market Reaction - Following the financial announcement, Outset Medical's stock price dropped by $5.85 per share, or 48.47%, closing at $6.22 per share on November 11, 2025 [5].

Core Insights - Class actions have been initiated for stockholders of James Hardie Industries plc and Baxter International, Inc. with specific deadlines for lead plaintiff petitions [1] James Hardie Industries plc (NYSE:JHX) - The class period for the James Hardie lawsuit is from May 20, 2025, to August 18, 2025 [6] - Allegations include that James Hardie's North America Fiber Cement segment faced weakening demand due to distributor inventory destocking, which the company was aware of by April and early May 2025 [6] - The company falsely represented that demand remained strong and inventory levels were "normal" [6] - On August 19, 2025, a 12% sales decline in the segment was revealed, attributed to "normalization of channel inventories," leading to a share price drop of over 34% [6] Baxter International, Inc. (NYSE:BAX) - The class period for the Baxter lawsuit is from February 23, 2022, to July 30, 2025 [6] - Allegations state that the Novum LVP suffered systemic defects causing malfunctions, which exposed patients to serious risks [6] - Baxter was reportedly notified of multiple device malfunctions, injuries, and deaths related to these defects [6] - The company's attempts to address these issues through customer alerts were deemed inadequate, as design flaws persisted [6] - There was a heightened risk that existing Novum LVPs would be taken out of service, and new sales would be paused, contradicting Baxter's statements about the product's safety and efficacy [6]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Baxter International Inc. common stock between February 23, 2022, and July 30, 2025, of the December 15, 2025, deadline to become a lead plaintiff in a class action lawsuit [1] Group 1: Class Action Details - Investors who bought Baxter common stock during the specified period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2] - To join the class action, interested parties can visit the provided link or contact the law firm for more information [3][6] - A lead plaintiff is required to file a motion with the Court by December 15, 2025, to represent other class members in the litigation [3] Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4] - The firm has achieved significant settlements, including the largest securities class action settlement against a Chinese company at the time, and has consistently ranked highly in securities class action settlements [4] - In 2019, the firm secured over $438 million for investors, showcasing its capability in recovering funds for clients [4] Group 3: Case Allegations - The lawsuit alleges that Baxter misled investors by failing to disclose systemic defects in the Novum IQ Large Volume Pump, which led to serious risks for patients [5] - Specific issues included malfunctions such as underinfusion, overinfusion, and complete non-delivery of fluids, which resulted in injuries and deaths [5] - Baxter's inadequate responses to these defects and the potential halting of new sales of the pumps contributed to misleading statements regarding the product's safety and sales prospects [5]

INSP CLASS REMINDER: Inspire Medical Systems, Inc. Investors with Losses are Reminded to Contact BFA Law before the Imminent January 5 Securities Class Action DeadlineNovember 28, 2025 8:18 AM EST | Source: Bleichmar Fonti & AuldNew York, New York--(Newsfile Corp. - November 28, 2025) - Leading securities law firm Bleichmar Fonti & Auld LLP announces that a class action lawsuit has been filed against Inspire Medical Systems, Inc. (NYSE: INSP) and certain of the Company's senior executives for ...

Core Insights - Profound Medical Corp. is launching the TULSA-AI Volume Reduction module for treating benign prostatic hyperplasia (BPH) at the RSNA meeting, enhancing the TULSA Procedure's versatility and potential for mainstream adoption [1][4] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on AI-powered, MRI-guided, incision-free therapies for ablation of diseased tissue [9][10] - The TULSA Procedure™ is the only incision-free option for prostate cancer and BPH, utilizing real-time MRI guidance for precision [3][10] Product Details - The TULSA-AI Volume Reduction module allows for efficient stacking of multiple prostate cases in one day, improving workflow and reducing procedure times [3][4] - The TULSA Procedure has shown significantly reduced risks of sexual function loss and incontinence compared to traditional methods, with superior outcomes in blood loss, length of stay, post-operative pain, and recovery time [3][4] Market Potential - The launch of the TULSA-AI module is expected to triple Profound's total available market in prostate disease to approximately 600,000 patients annually [4] - The TULSA Procedure is positioned to become a mainstream treatment across various prostate disease conditions, including low-, intermediate-, and high-risk prostate cancer, as well as BPH [10] Event Participation - Profound Medical will showcase the TULSA-AI Volume Reduction module and present new clinical data at the RSNA and SUO meetings [5][6][7]

Company Overview - Medtronic plc, based in Galway, Ireland, develops, manufactures, and sells device-based medical therapies, with a market cap of $134.7 billion [1] - The company's principal products address various medical conditions, including bradycardia pacing, tachyarrhythmia management, atrial fibrillation management, heart failure management, heart valve replacement, pain management, and movement disorders [1] Market Position - Medtronic is classified as a large-cap stock, with a market cap exceeding $10 billion, highlighting its size and influence in the medical devices industry [2] - The company has a diverse geographic reach, with approximately half of its sales coming from international markets, which helps mitigate economic risks [2] Stock Performance - Medtronic shares reached a 52-week high of $106.33 recently, with a 13.9% gain over the past three months, outperforming the iShares U.S. Medical Devices ETF's (IHI) 3.4% gains [3] - Year-to-date, Medtronic shares have risen 31.5%, and over the past 52 weeks, they have climbed 22.6%, again outperforming IHI's YTD gains of 10.3% and 6% returns [4] Recent Financial Results - On November 18, Medtronic reported Q2 results, with an adjusted EPS of $1.36, exceeding Wall Street's expectations of $1.31, and revenue of $9 billion, surpassing the forecast of $8.9 billion [5] - The company anticipates full-year adjusted EPS in the range of $5.62 to $5.66 [5] Competitive Landscape - In comparison, Abbott Laboratories (ABT) has shown a YTD gain of 13.6% and a 9% increase over the past 52 weeks, indicating that Medtronic is outperforming its competitor in the medical devices sector [5]

Core Insights - Boston Scientific Corporation (BSX) is a leading player in the medical devices industry with a market cap of $149.7 billion, focusing on various interventional medical specialties globally [1][2] Company Overview - BSX develops, manufactures, and markets medical devices for interventional cardiology, cardiac rhythm management, peripheral interventions, electrophysiology, neurovascular intervention, and endoscopy [1] - The company is categorized as a large-cap stock, emphasizing its size and influence in the medical devices sector [2] - Key strengths of BSX include a trusted brand, innovation driven by R&D, a diversified product portfolio, global reach, and strategic acquisitions [2] Stock Performance - BSX shares have experienced a decline of 7.8% from their 52-week high of $109.50, reached on September 9 [3] - Over the past three months, BSX stock has decreased by 5.1%, underperforming the Nasdaq Composite, which gained 7.8% during the same period [3] - Year-to-date, BSX shares have risen by 13%, and over the past 52 weeks, they have climbed 11.9%, but still lag behind the Nasdaq's YTD gains of 20.2% and 21.1% over the last year [4] Recent Financial Results - On October 22, BSX reported Q3 results, with an adjusted EPS of $0.75, exceeding Wall Street's expectation of $0.71 [5] - The company's revenue for the quarter was $5.1 billion, surpassing the forecast of $5 billion [5] - BSX anticipates full-year adjusted EPS in the range of $3.02 to $3.04 [5] Competitive Landscape - In comparison, Stryker Corporation (SYK) has shown weaker stock performance, with a YTD gain of only 3.4% and a 4.5% decline over the past 52 weeks [5]

Core Viewpoint - Rosen Law Firm is urging investors of DexCom, Inc. to take action before the December 29, 2025 deadline for a securities class action related to misleading statements made by the company during the class period from July 26, 2024, to September 17, 2025 [1][5]. Group 1: Class Action Details - Investors who purchased DexCom securities during the specified class period may be eligible for compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - To participate in the class action, investors must act before the lead plaintiff deadline of December 29, 2025, and can do so by contacting Rosen Law Firm [3][6]. - The lawsuit alleges that DexCom made unauthorized design changes to its G6 and G7 continuous glucose monitoring systems, which compromised their reliability and posed health risks to users [5]. Group 2: Legal Representation - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a proven track record in securities class actions, highlighting its own success in recovering significant amounts for investors [4]. - The firm has been recognized for its leadership in securities class action settlements, achieving the largest settlement against a Chinese company and ranking highly in the number of settlements since 2013 [4].

Core Viewpoint - Nyxoah is actively participating in the Piper Sandler 37th Annual Healthcare Conference, showcasing its innovative solutions for Obstructive Sleep Apnea (OSA) treatment [1]. Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [3]. - The company aims to improve the quality of life for OSA patients, allowing them to enjoy restful nights [3]. Product Development and Regulatory Approvals - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4]. - Nyxoah has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4]. - The company expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study, which are currently contraindicated in competitors' therapies [4]. - Nyxoah announced positive results from the DREAM IDE pivotal study and received FDA approval for a subset of adult patients with moderate to severe OSA, specifically those with an Apnea-Hypopnea Index (AHI) of 15 to 65 [4].

Core Viewpoint - Investors are increasingly seeking growth stocks that demonstrate above-average growth potential, particularly in the financial sector, to achieve exceptional returns. However, identifying such stocks can be challenging due to inherent volatility and risks associated with growth stocks [1]. Group 1: Company Overview - LeMaitre Vascular (LMAT) is identified as a promising growth stock, supported by a favorable Growth Score and a top Zacks Rank [2]. - The company has a historical EPS growth rate of 14.3%, with projected EPS growth of 30.1% for the current year, significantly outperforming the industry average of 12% [5]. Group 2: Financial Performance - LeMaitre's year-over-year cash flow growth stands at 35.1%, well above the industry average of 3.4%, indicating strong financial health and capacity for new projects [6]. - The company's annualized cash flow growth rate over the past 3-5 years is 18.1%, compared to the industry average of 8.5%, showcasing consistent performance [7]. Group 3: Earnings Estimates - The current-year earnings estimates for LeMaitre have been revised upward, with the Zacks Consensus Estimate increasing by 4.1% over the past month, reflecting positive market sentiment [9]. - LeMaitre has achieved a Zacks Rank of 2 (Buy) and a Growth Score of B, indicating its potential as a solid choice for growth investors [11].