Core Viewpoint - Inspire Medical Systems, Inc. is facing a class action lawsuit for securities fraud following a significant stock drop attributed to alleged violations of federal securities laws [1][3]. Group 1: Lawsuit Details - The class action lawsuit has been filed against Inspire Medical Systems and certain senior executives, with claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 [3]. - Investors have until January 5, 2026, to request to lead the case, which is pending in the U.S. District Court for the District of Minnesota [3]. Group 2: Company Background - Inspire Medical Systems develops an implantable medical device for treating sleep apnea, with the latest version being the Inspire V, which received FDA approval on August 2, 2024 [4]. Group 3: Stock Performance and Issues - Inspire assured investors of a timely launch for Inspire V, but failed to adequately prepare clinicians and payors, leading to delays and weak demand due to excess inventory of older devices [5][6]. - On August 4, 2025, Inspire announced an "elongated timeframe" for the Inspire V launch and reduced its 2025 earnings per share guidance by over 80%, causing the stock price to drop by $42.04, or more than 32%, from $129.95 to $87.91 per share [7][8].

Core Viewpoint - Picard Medical, Inc. will present in vitro data on its fully implantable Emperor Total Artificial Heart at the ISMCS 2025 conference, highlighting advancements in patient mobility and quality of life [1][3]. Group 1: Presentation Details - The presentation is scheduled for December 4, 2025, at 14:05 CET during the Mini Oral Session 3 focused on Hemocompatibility and Heart/Pump Interaction [2]. - The title of the presentation is "The Emperor Total Artificial Heart: A Next Generation, Fully Implantable Total Artificial Heart," and it will be presented by Duffy Elmer, Engineering Project Manager at Picard Medical [2]. Group 2: Product Information - The Emperor Total Artificial Heart features an internal motor-driven design that eliminates the need for an external pneumatic driver, aiming to enhance patient mobility and overall quality of life [3]. - Picard Medical, through its subsidiary SynCardia Systems, is the only company with commercially available total artificial heart technology for patients with end-stage heart failure, having performed over 2,100 implants across 27 countries [5]. Group 3: Event Information - ISMCS 2025 is the 31st annual global congress of the International Society for Mechanical Circulatory Support, bringing together various stakeholders to discuss new clinical research and emerging technologies in mechanical circulatory support [4].

Core Insights - Nyxoah's Genio therapy has received significant reimbursement increases for 2026 under the final CMS rule, which is expected to enhance the commercial rollout in the U.S. [1][3] - The reimbursement for the Genio system's CPT code 64568 will rise to approximately $45,000 for Hospital Outpatient Departments (HOPD), a 48% increase from 2025, and to $42,373 for Ambulatory Surgery Centers (ASC), reflecting a 58% increase [2][3] Summary by Sections Reimbursement Changes - The final CMS rule assigns CPT code 64568 to New Technology APC 1580, which strengthens the economic foundation for therapy adoption in U.S. hospitals and ASCs [1][3] - The reimbursement increases apply uniformly to all procedures billed under CPT 64568, supporting broader adoption and increased procedural throughput [3] Therapy Expansion Opportunities - The significant increase in ASC facility payment creates new opportunities for therapy expansion and diversification of service sites [4] - The Genio system's single-incision procedure is particularly well-suited for the ASC environment, enhancing its appeal [4] Company Background - Nyxoah is focused on developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio system, a leadless and battery-free hypoglossal neurostimulation therapy [5][6] - The company has received various regulatory approvals, including the European CE Mark in 2019 and FDA approval in August 2025 for specific patient subsets [6]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased DexCom, Inc. securities during the specified Class Period of the upcoming lead plaintiff deadline for a class action lawsuit [1][5]. Group 1: Class Action Details - Investors who purchased DexCom securities between July 26, 2024, and September 17, 2025, 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 must move the Court to serve as lead plaintiff by December 29, 2025 [3][5]. - The lawsuit claims that DexCom made unauthorized design changes to its G6 and G7 continuous glucose monitoring systems, which posed health risks to users [5]. Group 2: Allegations Against DexCom - The lawsuit alleges that DexCom's design changes rendered the G6 and G7 systems less reliable, overstating the devices' enhancements and functionality [5]. - It is claimed that DexCom downplayed the severity of issues related to the G7 devices, which increased the risk of regulatory scrutiny and potential legal repercussions [5]. - The public statements made by DexCom during the Class Period are described as materially false and misleading, leading to investor damages when the truth was revealed [5]. Group 3: Rosen Law Firm's Credentials - 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 at the time [4]. - The firm has been consistently ranked among the top firms for securities class action settlements and has recovered hundreds of millions of dollars for investors [4]. - In 2019, the firm secured over $438 million for investors, showcasing its effectiveness in representing investor rights [4].

Core Insights - Nova Eye is focusing on the clinical use of the iTrack Advance and is sharing insights from the field with the participation of Dr. Khaimi, a leading glaucoma surgeon [1][2] Group 1: Company Overview - Nova Eye's Medical CEO, Thomas Spurling, introduced Dr. Khaimi, highlighting his expertise in canal-based surgery and his significant contributions to the field [1][2] - Dr. Khaimi is recognized as one of the most experienced canal-based surgeons globally and has played a pivotal role in the development and rollout of the canaloplasty technique [2][3] Group 2: Product Development - The iTrack Advance product was developed in collaboration with Dr. Khaimi, focusing on ergonomics and functionality, with work dating back to 2022 [3] - Dr. Khaimi's extensive experience at the Dean McGee Eye Institute has contributed to the training of future glaucoma specialists and the advancement of glaucoma services [3]

Core Viewpoint - Class actions have been initiated on behalf of stockholders of DexCom, Inc. and Wildermuth Fund, with deadlines for investors to petition the court to serve as lead plaintiff [1]. DexCom, Inc. (NASDAQ:DXCM) - The class action alleges that during the class period from January 8, 2024, to September 17, 2025, DexCom made materially false and misleading statements regarding its business and compliance policies [6]. - Specific allegations include unauthorized design changes to the G6 and G7 devices that rendered them less reliable, presenting health risks to users [6]. - The complaint claims that the enhancements to the G7 were overstated and that the true scope of issues with the devices was downplayed, leading to increased regulatory scrutiny and potential legal and financial harm [6]. Wildermuth Fund (NASDAQ:WEFCX, NASDAQ:WESFX, NASDAQ:WEIFX) - The class action for Wildermuth Fund covers the period from November 1, 2020, to June 29, 2023, with a lead plaintiff deadline of December 29, 2025 [6]. - Allegations include miscalculating the fair value of the Fund's investments and failing to disclose financial support for portfolio companies with questionable viability [6]. - The complaint also states that the Fund intentionally inflated its net asset value, resulting in excessive advisory fees, which harmed class members [6].

Core Viewpoint - Rosen Law Firm is reminding investors of DexCom, Inc. about the upcoming deadline for a securities class action lawsuit, encouraging them to secure legal counsel before December 29, 2025 [1][2]. Group 1: Class Action Details - Investors who purchased DexCom securities between July 26, 2024, and September 17, 2025, may be entitled to 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 join by submitting a form or contacting the law firm [3][6]. Group 2: Allegations Against DexCom - 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 DexCom overstated the enhancements and reliability of the G7 devices while downplaying the severity of the issues, leading to increased regulatory scrutiny and potential legal repercussions [5].

Core Insights - Align Technology, Inc. has received top-tier recognition in the 2025 All-America Executive Team rankings published by Extel Insights, highlighting its leadership in the medical device sector [1] Company Overview - Align Technology is a leading global medical device company that specializes in designing, manufacturing, and selling the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry [1]

Core Viewpoint - A class action lawsuit has been filed against DexCom, Inc. alleging that the company made misleading statements regarding the reliability and safety of its G6 and G7 glucose monitoring devices, which were modified without FDA approval, leading to health risks for users [2][4]. Summary by Sections Lawsuit Details - The lawsuit claims that DexCom made unauthorized design changes to the G6 and G7 devices, which compromised their reliability and presented health risks to users [2]. - Allegations include overstating the enhancements and reliability of the G7, downplaying the severity of issues with the devices, and exposing the company to increased regulatory scrutiny and potential legal consequences [2]. Regulatory Concerns - On March 7, 2025, DexCom received a warning letter from the FDA regarding manufacturing and quality management issues, resulting in a share price drop of $7.12, or approximately 9.15%, from $77.84 to $70.72 [3]. - The FDA's published warning letter on March 25, 2025, confirmed that DexCom had adulterated its devices, leading to a further decline in share price by $1.77, or about 2.4%, from $75.32 to $73.55 [4]. Market Reactions - On September 8, 2025, Oppenheimer downgraded DexCom's rating to "perform" from "outperform," citing concerns over the G7's accuracy and performance, which caused a decline in share price by $2.51, or approximately 3.1%, from $80.51 to $78.00 [5]. - A report by Hunterbrook Media LLC on September 18, 2025, highlighted severe health risks associated with the G7 devices, linking them to hospitalizations and fatalities, resulting in a significant share price drop of $8.33, or about 11%, from $75.78 to $67.45 [7].

Group 1 - Berger Montague is advising shareholders of Baxter International Inc. regarding an investigation into the Board of Directors for potential breaches of fiduciary duties related to the marketing and sale of the Novum Large Volume Pump [1] - The investigation focuses on whether the Board of Directors properly oversaw the marketing and sale of the Novum LVP, which is used for controlled delivery of intravenous fluids [1] - In July 2025, Baxter announced a voluntary and temporary pause in shipments and planned installations of the Novum LVP [1] Group 2 - Berger Montague is a prominent law firm specializing in complex civil litigation, class actions, and mass torts, with over $2.4 billion in post-trial judgments in 2025 [1] - The firm has recovered over $50 billion for clients and represented classes in various legal areas for over 55 years [1]