New York, New York--(Newsfile Corp. - November 10, 2025) - If you suffered a loss on your Baxter International, Inc. (NYSE: BAX) investment and want to learn about a potential recovery under the federal securities laws, follow the link below for more information:https://zlk.com/pslra-1/baxter-international-inc-lawsuit-submission-form?prid=176438&wire=5&utm_campaign=23or contact Joseph E. Levi, Esq. via email at jlevi@levikorsinsky.com or call (212) 363-7500 to speak to our team of experienced shareholder a ...

Core Insights - INBRAIN Neuroelectronics has announced a strategic collaboration with Microsoft to enhance agentic AI for precision neurology and brain-computer interface (BCI) therapeutics [1][2] - The partnership aims to utilize Microsoft's Azure AI infrastructure to enable INBRAIN's platform to learn and adapt to individual patient signals in real time [2][3] - This collaboration is expected to transform the monitoring and treatment of neurological disorders, offering closed-loop precision interventions for conditions like Parkinson's disease and epilepsy [2][3] Company Overview - INBRAIN Neuroelectronics is pioneering real-time precision neurology with the world's first graphene-based BCI therapeutics platform [5] - The technology combines precise BCI decoding with micrometric modulation to provide adaptive, personalized treatments for various neurological conditions [5] - The platform aims to maximize therapeutic outcomes while minimizing side effects through continuous real-time monitoring and autonomous therapy adjustments [5] Technological Advancements - The collaboration will integrate advanced decoding and modulation with agentic AI, enabling personalized, data-driven modulation of neural circuits in real time [3] - INBRAIN's neural platform is built on graphene, known for its exceptional conductivity and biocompatibility, which enhances the effectiveness of BCI therapeutics [3][4] - The partnership underscores a commitment to ethical innovation and patient privacy in neurotechnology development [4]

Core Insights - Envoy Medical experienced a transformational third quarter in 2025, significantly improving its financial position by eliminating $32 million in debt and strengthening its balance sheet [2][5][6] - The company received FDA approval to expand its pivotal clinical trial to the final stage, which is expected to enhance its market position in fully implanted hearing solutions [2][8] - Envoy Medical's net revenue for the third quarter was $42 thousand, a decrease from $56 thousand in the same period of 2024 [5][17] Financial Highlights - Research and Development (R&D) expenses decreased by $57 thousand to $2.7 million compared to the same quarter in 2024, as the company transitioned from development to clinical trial phases [5][17] - General and administrative expenses increased by $752 thousand, primarily due to public company costs and expenses related to a September 2025 offering [5][17] - As of September 30, 2025, the company had approximately $3.556 million in cash, down from $5.483 million at the end of 2024 [6][15] Operational Developments - The company continued to receive additional global patents in the U.S., Europe, and Australia, reinforcing its position as a market leader in fully implanted hearing solutions [2][7] - The Acclaim Cochlear Implant, an investigational device, is designed to address severe to profound sensorineural hearing loss and has received Breakthrough Device Designation from the FDA [8][9] Market Position - Envoy Medical aims to capitalize on its first-mover advantage in the fully implanted hearing solutions market, with ongoing interest in its cochlear implant trial [2][8] - The company is dedicated to advancing hearing technology to improve access and quality of life for individuals with hearing loss [7][8]

Core Viewpoint - A class action lawsuit has been filed against DexCom, Inc. for securities fraud, alleging that the company misled investors about the reliability and accuracy of its continuous glucose monitoring systems, leading to significant stock declines [2][4]. Company Overview - DexCom, Inc. specializes in manufacturing continuous glucose monitoring (CGM) systems, including the Dexcom G6 and G7 models [5]. Allegations and Issues - The lawsuit claims that DexCom made unauthorized design changes to the G6 and G7, which compromised the accuracy of the devices and posed potential health risks to customers [6]. - The company allegedly prioritized cost-cutting over safety, ignoring critical safety issues [6]. Stock Performance and Impact - DexCom's stock experienced significant declines due to revelations about quality issues: - On March 7, 2025, the stock fell by $7.12 per share (over 9%) following an FDA warning letter regarding manufacturing concerns [7]. - After the FDA's public disclosure on March 25, 2025, the stock dropped another $3.19 per share (over 4%) [8]. - A report published on September 18, 2025, led to a nearly 12% decline, with the stock dropping $8.99 per share over two trading days [9].

Core Insights - Inspire Medical Systems reported strong third quarter results, driven by robust adoption of the Inspire V system and operational discipline [1] - The company experienced significant growth in patient volume and positive clinical feedback, contributing to an expanding customer base both in the U.S. and internationally [1] - CEO Tim Herbert expressed enthusiasm regarding the performance of the Inspire V system and the positive reception of its simplified procedure and comfort settings [1] Financial Performance - Revenue for Q3 was $224.5 million, exceeding analyst estimates of $220.2 million, representing a 10.5% year-on-year growth [6] - EPS (GAAP) was $0.34, significantly beating analyst estimates of -$0.19 [6] - Adjusted EBITDA reached $44.08 million, surpassing analyst expectations of $24.72 million, with a margin of 19.6% [6] - The company reaffirmed its full-year revenue guidance at $905 million and EPS guidance at $0.95, both exceeding analyst estimates [6] Market Dynamics - Sales volumes increased by 13.6% year-on-year, although this was a decrease from the 23.8% growth in the same quarter last year [6] - Market capitalization stands at $2.38 billion [6] - CEO Tim Herbert indicated expectations for accelerated growth in 2026 following the rollout of Inspire V, with formal guidance to be provided in January [6] Strategic Initiatives - The company is focusing on transitioning high-volume centers to Inspire V by year-end, while some centers may continue using Inspire IV for specific reasons [6] - Inspire Medical Systems is implementing targeted initiatives to engage ENT surgeons and expand provider capacity, with early results anticipated to be more evident in 2026 [6] - The management team is monitoring competitive dynamics closely, noting that competition is still in early stages and has not significantly impacted growth [6]

Core Insights - UFP Technologies reported better-than-expected results for Q3, driven by strong growth in its MedTech business despite labor inefficiencies at its AJR Illinois facility [1] - Key segments such as Interventional and Surgical, Orthopedics, and Wound Care each grew over 30%, which helped offset a 23% decline in Patient Services and Support due to workforce turnover [1] Financial Performance - Revenue reached $154.6 million, exceeding analyst estimates of $149.6 million, representing a 6.5% year-on-year growth and a 3.3% beat [6] - Adjusted EPS was $2.39, beating analyst estimates of $2.17 by 10% [6] - Adjusted EBITDA was $30.74 million, surpassing estimates of $29.26 million, with a margin of 19.9% [6] - Operating margin decreased to 15.3% from 17.7% in the same quarter last year [6] - Market capitalization stands at $1.74 billion [6] Business Developments - CEO Jeff Bailly noted that while overall growth in robotic surgery was 5%, the primary customer experienced closer to 8% growth due to a one-year sales mix effect [6] - A contract expansion with the largest customer is anticipated to include all product lines and require new facility investments, with expected volume increases in future years [6] - Revenue expectations from two new robotic surgery programs are estimated at $10 million for the next year, described as conservative with potential upside in subsequent years [6] - The company is addressing a $16 million backlog and expects double-digit growth and improved efficiency as hiring and training progress [6] - Launch-related costs typically generate modest short-term losses, but these costs are expected to transition to profitability as new programs mature [6]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased DexCom, Inc. securities between July 26, 2024, and September 17, 2025, about the upcoming lead plaintiff deadline on December 29, 2025, for a class action lawsuit related to misleading statements made by the company [1]. Group 1: Class Action Details - Investors who purchased DexCom securities during the specified Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties can join by contacting Rosen Law Firm [3][6]. - The deadline to serve as lead plaintiff is December 29, 2025, which requires a motion to the Court [3]. Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting its own achievements, including the largest securities class action settlement against a Chinese company [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]. Group 3: Case Allegations - 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]. - It is claimed that the company downplayed the severity of issues related to the G7 devices, leading to increased regulatory scrutiny and potential legal and financial repercussions [5]. - The lawsuit asserts that the public statements made by DexCom were materially false and misleading, resulting in investor damages when the true information became public [5].

Core Insights - Hainan has introduced measures to support the high-end medical device and digital therapy industries, focusing on "high-end innovation" and "digital integration" to create a comprehensive support system covering research, registration, production, and application [2][3] Group 1: Industry Development - The biopharmaceutical industry is a key focus for Hainan's free trade port, with rapid growth driven by policy advantages [2] - The number of registered medical device companies in Hainan has increased from 64 in 2021 to 144 currently, while the total number of product registrations has risen from 146 to 548 [2] - The product structure is evolving from low-value consumables to high-value areas such as orthopedic implants, active devices, digital therapies, and AI software [2] Group 2: Policy Measures - The measures include support for high-end medical device innovation through real-world data application, establishment of high-level R&D platforms, and encouragement of collaboration among industry, academia, and healthcare [3] - For digital therapy, the measures propose a "green channel" for product registration, enhanced R&D guidance, and a mechanism for ongoing government-business communication [3] Group 3: Competitive Advantage - The implementation of these policies is expected to enhance Hainan's competitiveness in the medical device sector, positioning it as a hub for high-end medical device innovation and a global center for digital therapy [4]

Core Viewpoint - A class action lawsuit has been filed against Inspire Medical Systems, Inc. for misrepresentations regarding the market demand and launch of its sleep apnea device, Inspire V, during the specified Class Period from August 6, 2024, to August 4, 2025 [1][5]. Group 1: Lawsuit Details - The lawsuit claims that defendants made materially false and misleading statements about the demand for Inspire V and the necessary steps taken for its launch, leading to investor damages when the truth was revealed [5]. - Investors who purchased common stock during the Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. Group 2: Participation Information - Interested parties can join the class action by visiting the provided link or contacting the law firm directly for more information [3][6]. - A lead plaintiff must be appointed by January 5, 2026, to represent other class members in the litigation [1][3]. Group 3: Law Firm Credentials - The Rosen Law Firm has a strong track record in securities class actions, having achieved significant settlements, including the largest securities class action settlement against a Chinese company [4]. - The firm has consistently ranked highly in securities class action settlements and has recovered hundreds of millions of dollars for investors [4].

Core Insights - Edwards Lifesciences has announced its founding sponsorship of the American Heart Association's Heart Valve Initiative, aimed at improving care and outcomes for over 28 million people with heart valve disease globally, with more than 60,000 deaths annually in the U.S. attributed to valve disease [1][2]. Company Initiatives - The Heart Valve Initiative will focus on enhancing patient education, clinician training, and quality improvement to drive measurable impact in the treatment of heart valve disease [2][3]. - The initiative will expand the existing Target: Aortic Stenosis program, which was also founded through Edwards' sponsorship, over the next five years [3]. Goals and Objectives - The initiative aims to improve adherence to guideline-based care, starting with aortic stenosis, and will expand data collection to include asymptomatic and moderate cases [6]. - Plans include establishing a heart valve certification program for hospitals, advancing public reporting and hospital recognition, providing multimedia education for clinicians and patients, and launching a national awareness campaign to support informed care decisions [6].