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 [2][3]. 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 the company's assurances of a successful launch [3]. - Allegations include that the company 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 [3]. 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 [4]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [4]. Group 3: Legal Representation - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years and consistently ranking among the top securities litigation firms in the U.S. [5].

Core Insights - The FDA has approved a reduction in the mandatory enrollment size for the SAVE Surveillance Registry from 300 patients to 50 patients, indicating confidence in the safety of the QUELIMMUNE therapy with fewer patients [1] - The QUELIMMUNE therapy, designed for pediatric patients with acute kidney injury (AKI) and sepsis, has shown promising efficacy data, including a survival rate improvement from 50% to 70% at 90 days [3][8] - The reduction in registry size is expected to facilitate smoother adoption of QUELIMMUNE therapy, potentially expanding its market opportunity in the pediatric AKI sector, estimated at $100 million in the U.S. [4] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on treatments for critically ill patients facing organ failure, with its first product, QUELIMMUNE, approved in 2024 [12] - The QUELIMMUNE therapy utilizes the Selective Cytopheretic Device (SCD) to address hyperinflammation in patients, aiming to improve survival rates and reduce the need for dialysis [11] - The company has received recognition for its contributions to pediatric AKI treatment, including the 2025 Corporate Innovator Award from the National Kidney Foundation [9] Clinical Data - Preliminary results from the SAVE Surveillance Registry indicate zero device-related adverse events and a survival rate of 76% at Day 28 and Day 60, with a 71% survival rate at Day 90 [3][8] - Data from clinical studies show a 77% survival rate for patients treated with QUELIMMUNE compared to standard care, reflecting a 50% reduction in loss of life compared to historical data [8] - The SAVE Surveillance Registry has enrolled 32 pediatric patients to date, with the aim of confirming the safety of QUELIMMUNE therapy [2] Market Potential - The approval of QUELIMMUNE therapy is expected to enhance treatment options for pediatric patients with AKI, a condition that can lead to severe complications and increased healthcare costs [5][6] - The reduction in patient enrollment requirements is anticipated to accelerate the adoption of QUELIMMUNE therapy in medical institutions, thereby capturing a larger share of the pediatric AKI market [4]

Core Insights - Aethlon Medical, Inc. announced a pre-clinical study indicating the potential of the Hemopurifier device in treating Long COVID by targeting extracellular vesicles (EVs) [1][6][4] Company Overview - Aethlon Medical is focused on developing the Hemopurifier, a clinical-stage immunotherapeutic device aimed at treating cancer and life-threatening viral infections [7][8] - The Hemopurifier has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses [8] Long COVID Context - Long COVID affects an estimated 44 to 48 million people in the U.S., with a projected economic burden of $2 billion for those experiencing symptoms for a year [2] - Symptoms include fatigue, shortness of breath, and cognitive difficulties, persisting for weeks or months after initial COVID-19 infection [2] Research Findings - The study published on November 20, 2025, demonstrated that the Hemopurifier can remove harmful EVs from the blood, which are implicated in Long COVID [1][5] - Elevated levels of both large and small EVs were found in the plasma of Long COVID patients compared to recovered controls, indicating a potential therapeutic target [5][6] - The GNA affinity resin in the Hemopurifier was shown to deplete specific microRNAs associated with inflammatory pathways, suggesting a mechanism for reducing inflammation in Long COVID [5][6] Future Directions - Aethlon Medical plans to further investigate whether the removal of EVs can decrease SARS-CoV-2 viral particles, which may contribute to Long COVID pathogenesis [6]

Group 1 - The core viewpoint emphasizes the acceleration of high-level technological self-reliance and innovation as a means to lead new productive forces, as proposed by the 20th Central Committee's Fourth Plenary Session [1] - Zhejiang and Liaoning are actively implementing the spirit of the plenary session by seizing opportunities from the new round of technological revolution and industrial transformation [1] - Zhejiang is focusing on the deep integration of innovation chains, industrial chains, financial chains, and talent chains to enhance independent innovation capabilities [5] Group 2 - In Wenzhou, Zhejiang, a medical device company is benefiting from the collaboration with university researchers, leading to successful product development and market acceptance [3] - During the 14th Five-Year Plan period, Zhejiang has dispatched over 1,700 researchers to enterprises, addressing the challenges of converting academic research into practical innovations [5] - Zhejiang has more than 47,000 national high-tech enterprises, with a continuously improving technology achievement transformation system, placing it among the top regions in innovation capability in China [5] Group 3 - Liaoning has made significant breakthroughs in metal material enhancement, which has broad application prospects in aerospace and high-end equipment manufacturing [6] - The province is establishing a robust framework for technological innovation, including the creation of four provincial laboratories focusing on new materials, intelligent manufacturing, clean energy, and high-end equipment manufacturing [6] - Liaoning's annual growth rate of technology contract transactions exceeds 24%, indicating a strong transition of advanced research outcomes into productive capabilities [6]

Company Overview - Edwards Lifesciences Corporation, based in Irvine, California, has a market cap of $50.3 billion and specializes in products and technologies for treating advanced cardiovascular diseases, being the leading manufacturer of tissue heart valves and repair products [1][2]. Stock Performance - Edwards Lifesciences' stock reached a 52-week high of $87.40 on November 26 and is currently trading 2.4% below that peak. The stock has gained 4.8% over the past three months, outperforming the iShares U.S. Medical Devices ETF, which increased by 2.4% during the same period [3]. - Year-to-date, the stock has risen by 15.2% and 19.5% over the past 52 weeks, compared to the iShares U.S. Medical Devices ETF's gains of 9% in 2025 and 4.1% over the past year [4]. Financial Performance - In Q3, Edwards Lifesciences reported a 14.7% year-over-year increase in sales to $1.6 billion, exceeding expectations by 3.3%. The adjusted EPS of $0.67 surpassed consensus estimates by 13.6%. Despite these positive results, the stock dropped 1.2% in the trading session following the earnings release on October 30, but rebounded in the subsequent sessions [5]. Competitive Position - Edwards Lifesciences has outperformed its peer Stryker Corporation, which saw a 3.4% gain year-to-date and a 5.1% decline over the past 52 weeks. Among 31 analysts covering the stock, the consensus rating is a "Moderate Buy," with a mean price target of $93.68, indicating a 9.9% upside potential from current levels [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][2]. Group 1: Class Action Details - Investors who bought DexCom securities between July 26, 2024, and September 17, 2025, 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 [3]. 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 achievements in this area [4]. - The firm has secured significant settlements for investors, including over $438 million in 2019 alone, and has been recognized for its performance in securities class action settlements [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 DexCom's public statements regarding the reliability and functionality of these devices were materially false and misleading, leading to increased regulatory scrutiny and potential financial harm [5].

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Tandem Diabetes Care, Inc. due to allegations of misleading business information [1] Group 1: Legal Action and Investor Rights - Investors who purchased Tandem Diabetes Care securities may be entitled to compensation through a class action without any out-of-pocket fees [2] - The Rosen Law Firm is preparing a class action to seek recovery of investor losses [2] Group 2: Company Incident and Stock Impact - On August 7, 2025, Tandem Diabetes Care announced a voluntary medical device correction for select t:slim X2 insulin pumps due to a potential speaker-related issue, which led to a 19.9% drop in stock price on the same day [3] Group 3: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company and being ranked highly for settlements since 2013 [4] - The firm has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 [4]

As filed with the U.S. Securities and Exchange Commission on December 1, 2025. Registration No. 333-290927 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) Delaware 3842 86-1369123 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (IRS Employer Identification ...

As filed with the U.S. Securities and Exchange Commission on December 1, 2025. Registration No. 333-290927 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) Delaware 3842 86-1369123 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (IRS Employer Identification ...

NEW YORK, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Inspire Medical Systems, Inc. ("Inspire Medical Systems, Inc." or the "Company") (NYSE: INSP) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Inspire Medical Systems, Inc. investors who were adversely affected by alleged securities fraud between August 6, 2024 and August 4, 2025. Follow the link below to get more information and be contacted by a member of our team ...