Workflow
Medical Devices
icon
Search documents
Levi & Korsinsky Reminds Shareholders of a Lead Plaintiff Deadline of January 5, 2026 in Inspire Medical Systems, Inc. Lawsuit – INSP
Globenewswire· 2025-11-17 20:48
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 Systems' new product, Inspire V, was unsuccessful due to poor demand and excess inventory at treatment centers, contradicting prior assurances from the company [2] - Allegations include that Inspire Medical Systems failed to complete essential tasks for the product launch, such as training for treatment center customers, setting up IT systems, and ensuring proper Medicare reimbursement [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 this [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Legal 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]
INSP SECURITIES ALERT: BFA Law Notifies Inspire Medical Systems, Inc. Investors of Important January 5 Securities Class Action Deadline
Newsfile· 2025-11-17 20:18
INSP SECURITIES ALERT: BFA Law Notifies Inspire Medical Systems, Inc. Investors of Important January 5 Securities Class Action DeadlineNovember 17, 2025 3:18 PM EST | Source: Bleichmar Fonti & AuldNew York, New York--(Newsfile Corp. - November 17, 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 securities fraud after a signifi ...
DXCM Announcement: Contact Kessler Topaz Meltzer & Check, LLP About the Securities Fraud Class Action Lawsuit Filed Against DexCom, Inc. (DXCM)
Prnewswire· 2025-11-17 18:36
Core Viewpoint - A securities class action lawsuit has been filed against DexCom, Inc. for alleged misleading statements and undisclosed material changes to its glucose monitoring systems during the specified class period from January 8, 2024, to September 17, 2025 [1][3]. Group 1: Allegations Against DexCom - The complaints allege 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 [3]. - It is claimed that DexCom overstated the enhancements and reliability of the G7 device, downplaying the severity of issues related to adulterated devices [3]. - The allegations suggest that these actions increased DexCom's exposure to regulatory scrutiny and potential legal, reputational, and financial harm [3]. Group 2: Legal Process and Investor Actions - Investors who suffered losses can seek to be appointed as lead plaintiffs by December 26, 2025, or may choose to remain absent class members [4]. - The lead plaintiff will represent the interests of all class members and select legal counsel for the case [4]. - Kessler Topaz Meltzer & Check, LLP encourages affected investors to contact them for more information regarding the lawsuit [5].
NRXS Stock Declines Post Q3 Earnings Despite Continued Revenue Growth
ZACKS· 2025-11-17 18:21
Core Insights - NeurAxis, Inc. (NRXS) shares have declined 8.6% since the Q3 2025 earnings report, underperforming the S&P 500 Index's 1.7% decline during the same period [1] - The stock has experienced a significant drop of 36.4% over the past month, contrasting with a slight growth of 0.1% in the S&P 500 [1] Financial Performance - Q3 2025 revenues reached $0.8 million, a 21.7% increase from $0.7 million in the same quarter last year, marking the fifth consecutive quarter of double-digit growth [2] - Unit deliveries increased by 38% year over year, driven by the financial assistance program that provides discounted devices to uninsured patients [2] - Operating loss widened to $2.1 million from $1.7 million a year earlier, primarily due to a 125.3% year-over-year increase in selling expenses outpacing revenue growth [2] Margins and Losses - Gross margin decreased to 83.3% from 85.4%, attributed to increased discounting and expired inventory charges related to the Rectal Expulsion Device (RED) [3] - Net loss for the quarter was $2.1 million, compared to $1.8 million in the prior-year quarter [3] Liquidity and Cash Flow - NeurAxis ended the quarter with $4.4 million in cash and improved its liquidity by raising an additional $2.8 million through an equity offering and warrant exercises in October 2025 [4] - Free cash flow burn remained stable at approximately $1.5 million for the quarter, with increased inventory purchases in anticipation of demand once reimbursement improves [4] Management Insights - Management believes Q3 2025 set the stage for a significant scaling phase expected to begin in 2026, with a new CPT Category I code effective January 1, 2026, anticipated to streamline billing and reduce administrative hurdles [6] - Executives highlighted efforts to enhance payer engagement, supported by new clinical practice guidelines and outreach to large insurers, aiming for broader national medical policy coverage [6] Revenue Drivers and Expenses - Revenue growth was primarily driven by increased patient volume, particularly from the financial assistance program, and the soft launch of the RED product line [7] - Operating expenses rose significantly due to higher commissions from increased sales activity, targeted advertising, and preparatory spending ahead of the new CPT code launch [7] R&D and Administrative Costs - Research and development expenses increased by 3.6% year over year as NeurAxis continued to invest in clinical programs related to expanded FDA indications [8] - General and administrative costs rose by 7.2% year over year due to a new long-term incentive plan and system-related expenditures [8] Future Guidance - While no formal numerical guidance was provided, management expressed confidence in continued revenue growth for Q4 2025, supported by strong provider momentum [9] - The outlook for 2026 includes expectations for improved reimbursement clarity and broader patient access, although policy changes are anticipated to occur gradually [9][10] Regulatory and Market Developments - NeurAxis achieved several regulatory milestones, including FDA clearances for expanded indications of IB-Stim and the RED device for anorectal function testing [11] - The company secured academic society guideline recommendations for its technology, expanded total covered lives to approximately 55 million, and received a new Category I CPT code effective January 1, 2026, enhancing long-term reimbursement prospects [12]
Medtronic Q2 2026 Earnings Preview (NYSE:MDT)
Seeking Alpha· 2025-11-17 16:07
To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh. ...
Best Momentum Stock to Buy for Nov. 17th
ZACKS· 2025-11-17 16:01
Group 1: Roku - Roku is the leading TV streaming platform provider in the United States, Canada, and Mexico, with a Zacks Rank 1 (Strong Buy) [1] - The Zacks Consensus Estimate for Roku's current year earnings increased by 83.3% over the last 60 days [1] - Roku's shares gained 8% over the last three months, outperforming the S&P 500's gain of 4.5% [2] Group 2: Northrim BanCorp - Northrim BanCorp is a full-service commercial bank offering a complete range of personal and business banking services, with a Zacks Rank 1 [2] - The Zacks Consensus Estimate for Northrim BanCorp's current year earnings increased by 6.4% over the last 60 days [2] - Northrim BanCorp's shares gained 6.5% over the last three months, also outperforming the S&P 500's gain of 4.5% [3] Group 3: Electromed - Electromed manufactures, markets, and sells products that provide airway clearance therapy to patients with compromised pulmonary function, holding a Zacks Rank 1 [3] - The Zacks Consensus Estimate for Electromed's current year earnings increased by 2.9% over the last 60 days [3] - Electromed's shares gained 28.3% over the last three months, significantly outperforming the S&P 500's gain of 4.5% [4]
5 Top Stocks Driven by Strong Relative Price Strength Now
ZACKS· 2025-11-17 15:36
Market Overview - U.S. stocks have shown resilience, maintaining a strong upswing despite volatility, with major indexes near record levels supported by robust corporate earnings and investor appetite [1][2] - The end of the government shutdown has alleviated concerns, allowing for a more optimistic outlook on gradual policy easing from the Federal Reserve [2] Investment Strategy - A relative price strength strategy is recommended, focusing on stocks that outperform the market even during pauses, which helps investors align with market leadership [3][4] - Stocks that exceed their industry or benchmark performance should be prioritized for inclusion in investment portfolios, as they are more likely to yield significant returns [5] Stock Screening Criteria - Stocks should demonstrate positive relative price changes over 1, 4, and 12 weeks, outperforming the S&P 500 [8] - The screening highlights five stocks with strong relative price strength amid market gains, including Par Pacific Holdings, AngloGold Ashanti, Globus Medical, Allient Inc., and Sandisk Corporation [8] Company Highlights - **Par Pacific Holdings (PARR)**: Market cap of $2.2 billion, with a 146.2% share gain over the past year and a 112.3% increase in 2025 earnings estimates [11][8] - **AngloGold Ashanti (AU)**: Market cap over $33 billion, with a 220% share gain in the past year and a 162.4% year-over-year growth in 2025 earnings estimates [12][11] - **Globus Medical (GMED)**: Expected EPS growth rate of 14.3%, with a 3.2% share increase in a year and a positive revision in earnings estimates [13][14] - **Allient Inc. (ALNT)**: Market cap nearly $900 million, with a 117.7% share gain in a year and a 5.2% increase in 2025 earnings estimates [15][16] - **Sandisk Corporation (SNDK)**: Market cap of $37.3 billion, with a 422.9% share gain in a year and a 308% growth in fiscal 2026 earnings estimates [17][18]
2 Giant Healthcare Stocks to Buy Hand Over Fist in November
Yahoo Finance· 2025-11-17 15:00
Core Insights - The healthcare sector is characterized by high competition, regulation, and technical complexity, making it advisable for most investors to focus on larger companies within the industry [1] Group 1: Industry Overview - The healthcare sector often sees mergers and acquisitions, with larger companies acquiring innovations from smaller firms [2] - The regulatory burden in healthcare is significant, requiring substantial financial resources and time for new treatments to gain approval, which smaller companies often struggle to manage [3] - Post-approval, marketing a product demands considerable spending, which larger companies are better equipped to handle compared to smaller firms [4] Group 2: Company Analysis - Medtronic, with a market capitalization of $120 billion, is a leading medical device manufacturer known for its attractive dividend yield and long history of dividend growth [5][6] - Pfizer, valued at $145 billion, is a major pharmaceutical company actively working to rebuild its drug pipeline, making it a strong choice for long-term investors [5][7] - Medtronic's dividend yield is approximately 3%, with a history of 48 consecutive years of dividend increases, positioning it close to becoming a Dividend King [8]
Take the Zacks Approach to Beat the Markets: Macy's, United Natural Foods & Monster Beverage in Focus
ZACKS· 2025-11-17 14:42
Market Performance - Major U.S. indexes showed mixed performance last week, with the Nasdaq Composite, S&P 500, and Dow Jones Industrial Average declining by 2.7%, 1.4%, and 0.5% respectively [1] - Investors are shifting focus from high-valuation technology and AI stocks to more defensive sectors due to market volatility [1] Federal Reserve and Economic Data - The end of a 43-day government standoff has reduced political risks, but delays in key economic data releases have created uncertainty for the Federal Reserve and investors [2] - The Fed is balancing economic growth and inflation, with inflation remaining above the 2% target and a resilient labor market casting doubt on December rate cut expectations [2] Zacks Research Performance - Zacks Research has provided guidance that led to significant stock performance, with Macy's shares increasing by 14.9% since its upgrade to Zacks Rank 1 on September 18, outperforming the S&P 500's 2.2% increase [3][4] - Fresnillo plc also saw a 7.2% return since its upgrade to Zacks Rank 1 on September 19, compared to the S&P 500's 1.8% increase [4] Zacks Model Portfolio Returns - A hypothetical portfolio of Zacks Rank 1 stocks returned +8.64% in 2025 through September 1, outperforming the S&P 500's +7.60% [4] - The Zacks Model Portfolio has outperformed the S&P 500 index by over 12 percentage points since 1988, with an annualized average return of +23.8% compared to +11.3% for the S&P 500 [5] Specific Stock Performances - United Natural Foods, Inc. (UNFI) shares increased by 32.4% after its Zacks Recommendation was upgraded to Outperform [7] - Caterpillar Inc. (CAT) gained 35.9% over the past 12 weeks, while CACI International Inc. (CACI) returned 20.1% during the same period [10] Earnings Certain Admiral Portfolio (ECAP) - The ECAP returned -1.30% in Q3 2025, underperforming the S&P 500's +8.1% gain, and +2.72% year-to-date compared to the S&P 500's +14.84% [15] - The portfolio aims to minimize capital loss by holding shares of companies with a proven track record of earnings stability [16] Earnings Certain Dividend Portfolio (ECDP) - Johnson & Johnson (JNJ) returned 10.9% over the past 12 weeks, while UnitedHealth Group (UNH) increased by 5.9% [18] - The ECDP returned -0.01% in Q3 2025, underperforming the S&P 500's +8.1% gain [20] Top 10 Stock Portfolio - MasTec, Inc. (MTZ) has jumped 41.2% year-to-date, outperforming the S&P 500's 14.7% increase [22] - The Top 10 portfolio has produced a cumulative return of +2,553.1% since 2012, significantly outperforming the S&P 500's +545.2% [24]
Siemens to exit healthcare space with Healthineers deconsolidation
Yahoo Finance· 2025-11-17 14:37
Siemens has announced plans to ‘deconsolidate’ its remaining stake in Siemens Healthineers by transferring 30% of shares to Siemens shareholders. Siemens, whose stake had stood at 67%, will hand the shares over via a direct spin-off as ‘preferable option’. Deciding to deconsolidate the Healthineers business follows a thorough assessment and strategic review of how both companies can best realise their full potential, accelerate their respective transformations, and successfully tap into new areas of grow ...