Core Insights - Inspira Technologies has completed the clinical study for its non-invasive blood sensor, HYLA, and is preparing for regulatory submission and commercialization [1][2][4] - The HYLA sensor demonstrates an accuracy rate between 95% to 99% across various measured parameters, indicating its potential as a disruptive solution for real-time blood monitoring [2][4] - The company is integrating advanced Machine Learning algorithms to enhance the capabilities of the HYLA sensor, aiming to monitor critical physiological parameters not currently available through existing non-invasive systems [3][4] Company Overview - Inspira Technologies is a commercial-stage medical device company focused on advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA ART100 system [5] - The company is developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake, further expanding its product offerings [5] - Inspira Technologies is positioned as an attractive player in the life-support and MedTech landscape, with a growing intellectual property portfolio and strategic operational streamlining [5]

NEW YORK, Nov. 13, 2025 (GLOBE NEWSWIRE) -- 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 significant stock drop resulting from the potential violations of the federal securities laws. If you invested in Inspire, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/inspire-medical- ...

Core Viewpoint - A class action securities lawsuit has been filed against Baxter International, Inc. due to alleged securities fraud affecting shareholders between February 23, 2022, and July 30, 2025 [2][3]. Group 1: Lawsuit Details - The lawsuit claims that Baxter's Novum LVP product had systemic defects leading to malfunctions such as underinfusion, overinfusion, and non-delivery of fluids, posing serious risks to patients [3]. - It is alleged that Baxter was aware of multiple device malfunctions, injuries, and deaths related to these defects [3]. - Baxter's attempts to address these issues through customer alerts were deemed inadequate, as design flaws persisted and continued to harm patients [3]. - The lawsuit suggests that there was an increased risk of customers being instructed to take Novum LVPs out of service and that Baxter would halt all new sales of these pumps [3]. - Baxter's statements regarding the safety, efficacy, product rollout, customer feedback, and sales prospects of the Novum LVPs were claimed to be materially false and misleading [3]. Group 2: Next Steps for Affected Shareholders - Shareholders who suffered losses during the specified timeframe are encouraged to learn about their rights to seek recovery, with no cost or obligation to participate [4]. Group 3: Legal Representation - Levi & Korsinsky LLP is highlighted as a nationally-recognized securities litigation firm with a strong track record in securing recoveries for shareholders [5]. - The firm has over 20 years of experience and has been consistently ranked among the top securities litigation firms in the United States [5].

Core Insights - SINTX Technologies, Inc. reported third quarter financial results and provided a business update, focusing on its commercialization plan for infection-resistant silicon nitride devices and polymer composites [1][2]. Business Highlights and Key Milestones - The company received FDA 510(k) clearance for the SINAPTIC Foot & Ankle Osteotomy Wedge System, marking a significant milestone for commercial entry into reconstructive foot and ankle surgery in the U.S. [5][7]. - Initial product revenue was recorded from the OsseoSculpt™ product, a companion biologic to the SINAPTIC wedge portfolio [7]. - SINTX executed a sublease of the Armor facility, projected to save approximately $950,000 in lease costs, aligning resources with medical device priorities [7]. - The company raised an additional $4.3 million through warrant inducement and common stock warrant exercises, strengthening its liquidity [7]. Financial Results - Cash and cash equivalents increased to $6.25 million as of September 30, 2025, compared to $3.60 million on December 31, 2024 [7]. - Total revenue for Q3 2025 was $0.208 million, a decrease from $0.799 million in Q3 2024, primarily due to reduced grant revenue [7]. - Operating expenses were approximately $3.4 million, a 51% decrease year-over-year [7]. - The operating loss was $3.4 million, down from $6.4 million in Q3 2024, while the net loss was $3.5 million, or $1.19 per fully diluted share, compared to a net loss of $6.2 million, or $6.96 per fully diluted share in Q3 2024 [7]. Future Priorities - SINTX plans to prepare the SINAPTIC wedge system for launch, expand clinical engagement in targeted surgical specialties, and leverage its material science into adjacent indications [5]. - The company is also evaluating options for partnering, licensing, and capital formation to enhance market access and shareholder value [5].

Core Insights - OrthoPediatrics Corp. has expanded its OrthoPediatrics Specialty Bracing (OPSB) portfolio with the launch of two new products: the PediHip™ Rigid Brace and PediHip™ Modular Abduction Systems, bringing the total to 31 systems within the OPSB division [1][3] Product Development - The new PediHip™ products are designed for treating Developmental Dysplasia of the Hip (DDH) and for post-operative stabilization in pediatric patients aged three years and younger, enhancing treatment options for this condition [2] - The company emphasizes its commitment to organic new product development and collaboration with pediatric hip experts to advance care for children [3] Market Position - Founded in 2006, OrthoPediatrics focuses exclusively on pediatric orthopedics, offering over 85 products across three major categories: trauma and deformity, scoliosis, and sports medicine/other procedures [4] - The company distributes its products in the United States and over 70 countries, highlighting its global reach in the pediatric orthopedic market [4]

Core Viewpoint - Becton, Dickinson and Company (BDX) is a leading medical technology firm with a market cap of $54.2 billion, facing stock underperformance compared to broader market indices despite reporting strong revenue growth and positive earnings guidance for fiscal 2026 [1][2][4]. Company Overview - BDX develops, manufactures, and sells a wide range of medical devices, laboratory equipment, and diagnostic products, operating through three segments: BD Medical, BD Life Sciences, and BD Interventional [1]. Stock Performance - Over the past 52 weeks, BDX stock has decreased by 16.9%, while the S&P 500 Index has gained 14.5%. Year-to-date, BDX shares have declined by 15.3%, compared to a 16.5% rise in the S&P 500 [2][3]. Financial Performance - For the fourth quarter, BDX reported revenue of $5.9 billion, an 8.3% year-over-year increase, driven by strong demand in its medical and interventional segments. Adjusted EPS was $3.96, up from $3.81 a year earlier, slightly exceeding expectations [4]. Future Guidance - BDX has guided for fiscal 2026 adjusted EPS between $14.75 and $15.05, with analysts expecting a 3% year-over-year growth to $14.83 [4][5]. Analyst Ratings - Among 16 analysts covering BDX, the consensus rating is a "Moderate Buy," with six "Strong Buy" ratings, one "Moderate Buy," and nine "Holds." The company has a promising earnings surprise history, having beaten consensus estimates in the last four quarters [5]. Price Target - Piper Sandler analyst Jason Bednar reiterated a "Hold" rating on BDX and maintained a price target of $200 on the stock [6].

Company Overview - DexCom, Inc. (DXCM) is a leading medical-device company specializing in continuous glucose monitoring (CGM) systems for diabetes management, with a market capitalization of approximately $23.2 billion [1] Stock Performance - Over the past 52 weeks, DXCM stock has declined by 19.8%, while the S&P 500 Index has increased by 14.5%. Year-to-date, the stock is down 23.4%, compared to a 16.5% rise in the S&P 500 [2] - DexCom's shares have also underperformed the Health Care Select Sector SPDR Fund, which returned 3.8% over the past 52 weeks and 11.1% year-to-date [3] Earnings and Outlook - The company reported a solid third-quarter earnings performance, beating estimates; however, management's outlook indicated that growth in 2026 may be slightly below market expectations, raising concerns among investors [4] - For the fiscal year ending December 2025, analysts project DexCom's earnings per share (EPS) to grow by 26.2% year-over-year to $2.07. The company's earnings surprise history is mixed, with two beats and two misses in the last four quarters [5] Analyst Ratings - Among 28 analysts covering DexCom, the consensus rating is a "Strong Buy," consisting of 21 "Strong Buys," one "Moderate Buy," and six "Hold" ratings [6] - The consensus rating has become slightly more bullish compared to three months ago, when there were 20 "Strong Buy" ratings [7] Price Targets - Bernstein SocGen Group recently lowered its price target for DexCom from $98 to $84 while maintaining an "Outperform" rating. The mean price target of $87.38 suggests a potential upside of 46.7% from current levels, while the highest target of $125 indicates a possible rally of 109.7% [7]

Group 1 - Preferred Bank (PFBC) has seen a 5.6% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Weatherford International plc (WFRD) has experienced an 8.6% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Insulet Corporation (PODD) has recorded a 6.5% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - PRA Group, Inc. (PRAA) has seen a 9.9% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - Alexander's, Inc. (ALX) has experienced a 7% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2]

Core Insights - The FDA has granted a label expansion for BrainsWay's Deep TMS™ system, making it the first and only TMS device cleared for treating patients aged 15 to 86 suffering from major depressive disorder (MDD) [1][2][3] - This clearance allows access to Deep TMS™ for adolescents aged 15 to 21, a demographic often underserved by traditional pharmacological treatments [2][3] - The approval was supported by a substantial dataset from 1,120 adolescents treated across 35 TMS centers in the U.S., demonstrating a 66.1% response rate and an average improvement of 12.1 points on the PHQ-9 scale after 36 treatment sessions [2][3] Company Overview - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS™ platform technology [4] - The company has obtained three FDA-cleared indications, including MDD, obsessive-compulsive disorder, and smoking addiction, backed by pivotal clinical studies [4] - BrainsWay aims to increase global awareness and access to Deep TMS, with ongoing clinical trials for various psychiatric, neurological, and addiction disorders [4] Market Impact - Approximately 5 million adolescents in the U.S. are estimated to have experienced a major depressive episode in the past year, highlighting the significance of this clearance for addressing an important segment of the MDD patient population [3] - The Deep TMS™ system is now indicated for both adults and adolescents, allowing clinicians to use the same system and established protocols for treatment [3] - MDD is a leading cause of disability globally, with a critical gap in accessible and effective therapies for patients who do not respond to traditional treatments [3]

Core Viewpoint - Inspire Medical Systems, Inc. is facing a class action lawsuit due to alleged false statements and misleading information regarding the launch of its Inspire V device, which has resulted in significant financial losses for investors [1][4][10]. Group 1: Class Action Lawsuit Details - The class action lawsuit is titled "City of Pontiac Reestablished General Employees' Retirement System v. Inspire Medical Systems, Inc." and covers the period from August 6, 2024, to August 4, 2025 [1]. - Investors have until January 5, 2026, to seek appointment as lead plaintiff in the lawsuit [1]. - The lawsuit alleges that Inspire Medical and its executives violated the Securities Exchange Act of 1934 [1]. Group 2: Allegations Against Inspire Medical - The lawsuit claims that the launch of the Inspire V device was poorly executed, with significant surplus inventory and reluctance from providers to adopt the new treatment [4]. - It is alleged that Inspire Medical failed to complete essential tasks necessary for a successful launch, contrary to their assurances to investors [4]. - On August 4, 2025, Inspire Medical disclosed that the launch faced an "elongated timeframe" due to undisclosed challenges, including incomplete training and onboarding at implanting centers [5]. Group 3: Financial Impact - Following the negative news regarding the Inspire V launch, Inspire Medical reduced its 2025 earnings guidance by over 80% [5]. - The stock price of Inspire Medical declined by more than 32% after the announcement of these issues [5].