ROSEN, GLOBALLY RESPECTED INVESTOR COUNSEL, Encourages Inspire Medical Systems, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action - INSPDecember 01, 2025 4:03 PM EST | Source: The Rosen Law Firm PANew York, New York--(Newsfile Corp. - December 1, 2025) - WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of common stock of Inspire Medical Systems, Inc. (NYSE: INSP) between August 6, 2024 and August 4, 2025, both dates inclusive (the " ...

INSP SHAREHOLDERS: Inspire Medical Systems, Inc. Investors with Losses may have been Misled by the Company and are Urged to Contact BFA Law by January 5December 01, 2025 3:18 PM EST | Source: Bleichmar Fonti & AuldNew York, New York--(Newsfile Corp. - December 1, 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 ...

Core Viewpoint - Inspire Medical Systems, Inc. is facing a securities class action lawsuit due to allegations of misleading investors regarding the launch of its Inspire V device for obstructive sleep apnea, which resulted in a significant decline in stock price [1][3]. Group 1: Lawsuit Details - The lawsuit, titled City of Pontiac Reestablished General Employees' Retirement System v. Inspire Medical Systems, Inc., targets the company and its executives, representing investors who acquired stock between August 6, 2024, and August 4, 2025 [3]. - The complaint alleges violations of the Securities Exchange Act of 1934, claiming that management made false statements about the successful launch of the Inspire V device [3][7]. Group 2: Allegations Against Inspire Medical - The lawsuit claims that the transition to the Inspire V device was not seamless as promised, citing operational failures that hindered the launch [4]. - Key allegations include poor market demand due to existing inventory of the previous device, incomplete readiness for the rollout, and undisclosed logistical issues that affected billing and operational processes [10]. Group 3: Market Reaction - On August 4, 2025, Inspire Medical admitted to an "elongated timeframe" for the Inspire V launch, leading to a drastic reduction in 2025 earnings guidance by over 80% [5][6]. - Following this announcement, the company's stock price plummeted by over 32% on heavy trading volume, prompting the investor class action [6]. Group 4: Investigation Focus - Hagens Berman is investigating the claims against Inspire Medical, particularly focusing on potential misstatements or omissions related to the Inspire V launch and its financial implications [11]. - The investigation aims to determine if management was aware of critical operational flaws before the public disclosure on August 4 [12].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Baxter International Inc. common stock 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 Baxter common stock between February 23, 2022, and July 30, 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 can submit their information through the provided link or contact the law firm directly [3][6]. - The deadline to move the Court to serve as lead plaintiff is December 15, 2025 [3]. Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4]. - The firm has achieved significant settlements, including the largest securities class action settlement against a Chinese company at the time, and has consistently ranked highly in securities class action settlements [4]. - In 2019, the firm secured over $438 million for investors, showcasing its capability in recovering funds for clients [4]. Group 3: Case Allegations - The lawsuit alleges that Baxter misled investors by failing to disclose systemic defects in the Novum IQ Large Volume Pump, which led to serious malfunctions and risks to patient safety [5]. - Baxter was reportedly aware of multiple device malfunctions and injuries but did not take adequate remedial measures, leading to a heightened risk of product recalls and sales halts [5]. - The firm claims that Baxter's statements regarding the safety and efficacy of the Novum LVPs were materially false and misleading, resulting in investor damages when the truth was revealed [5].

Core Insights - SINTX Technologies has signed a supply agreement with Evonik Corporation to produce its proprietary SiN/PEEK composite material, enabling immediate production of AI-assisted patient-specific implants [1][2][3] - The SiN/PEEK material is designed for 3D printing of customized implants, addressing requests from doctors for vertebral body replacement implants for orthopedic and neurosurgical tumor patients [2][3] - The collaboration aims to combine Evonik's polymer manufacturing expertise with SINTX's silicon nitride biomaterials to meet critical clinical needs in trauma, spine, and oncology [2][3] Company Overview - SINTX Technologies, Inc. specializes in advanced ceramic materials, focusing on the development and commercialization of silicon nitride biomaterials and composites for medical applications [7] - The company has a strong patent portfolio and has developed thousands of medical devices since 2008, establishing itself as a leader in high-performance biomaterials [7] - SINTX is preparing to expand its production capabilities and regulatory submissions to address a broader range of indications beyond its current humanitarian focus [3][7] Material Advantages - SiN/PEEK offers superior pathogen-resistant surface properties, osteoconductive support, and enhanced imaging performance compared to standard PEEK [5][3] - The combination of silicon nitride and PEEK aims to provide additional clinical and economic value in complex implant indications [3][5] - The material supports greater design flexibility for patient-specific geometries through AI-assisted additive manufacturing [5][3] Strategic Collaboration - The agreement with Evonik is seen as a significant milestone for SINTX and the field of patient-specific implants, ensuring stable quality, reliable supply, and scalability for future collaborations [2][3] - Evonik's commitment to innovation in medical devices aligns with SINTX's goals to improve patient outcomes through advanced materials [2][3]

Core Insights - Bayer's MEDRAD® Centargo multi-patient CT injector has received 510(k) clearance from the U.S. FDA, allowing for the use of single-dose vials in addition to previously cleared Imaging Bulk Package presentations for various contrast agents [1] Group 1 - The FDA clearance expands the compatibility of the MEDRAD® Centargo injector to include single-dose vials for contrast agents such as Ultravist® (iopromide), Isovue® (iopamidol), Optiray® (ioversol), and Omnipaque™ (iohexol) [1]

Group 1 - Electromed, Inc. (ELMD) shares have increased by 11.3% over the past four weeks, closing at $26.77, with a mean price target of $36.67 indicating a potential upside of 37% [1] - The average price targets range from a low of $36.00 to a high of $38.00, with a standard deviation of $1.15, suggesting a strong agreement among analysts [2] - Analysts have shown increasing optimism regarding ELMD's earnings prospects, as indicated by a positive trend in earnings estimate revisions [11] Group 2 - The Zacks Consensus Estimate for the current year has increased by 2.9% over the last 30 days, with two estimates moving higher and no negative revisions [12] - ELMD holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] - While the consensus price target may not be a reliable indicator of potential gains, it does provide a directional guide for price movement [14]

Core Insights - Nyxoah (NYXH) has received a significant boost in reimbursement rates for its Genio hypoglossal nerve stimulation (HGNS) implants following the finalization of the CY2026 Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgery Center (ASC) Rule by the U.S. Centers for Medicare & Medicaid Services (CMS) [1][8] Group 1: Reimbursement Changes - The CPT Code 64568 for Genio implants has been assigned to New Technology Ambulatory Payment Classification (APC) 1580, leading to increased reimbursement rates [1][9] - The new reimbursement rate for hospital outpatient departments is approximately $45,000, reflecting a 48% increase from 2025 levels [9] - The ASC facility reimbursement rate is set at $42,373, which is a 58% increase compared to 2025 [9][10] Group 2: Market Impact - The increase in reimbursement rates is expected to enhance the adoption of Genio implants, driving procedural throughput and expansion in Medicare-heavy institutions [5][10] - The single-incision procedure of Genio is well-suited for the ASC environment, creating new opportunities for therapy expansion [10] - Despite a 40% decline in share price this year, the improved reimbursement landscape may positively influence Nyxoah's prospects in 2026 [4][5] Group 3: Product Approval and Market Position - The Genio implant is approved for treating obstructive sleep apnea (OSA) through neuromodulation, with initial CE mark received in 2019 [2] - FDA approval was granted in August for a subset of adult patients with moderate to severe OSA [3] - The recognition of hypoglossal nerve stimulation as a high-value therapy for OSA is reinforced by the significant reimbursement rate increases [10]

Market Overview - U.S. stock markets have continued to rise in 2025, with the Dow and S&P 500 gaining 0.3% and 0.1% in November, while the Nasdaq Composite fell by 1.5% [1][2] - Year-to-date performance shows the Dow, S&P 500, and Nasdaq Composite up by 12.6%, 16.7%, and 21.2%, respectively, with expectations of continued growth in December due to a potential interest rate cut by the Fed [3] Investment Opportunities - Recommended stocks for December include Expedia Group Inc. (EXPE), The Allstate Corp. (ALL), Dillard's Inc. (DDS), Kinross Gold Corp. (KGC), and Globus Medical Inc. (GMED), all carrying a Zacks Rank 1 (Strong Buy) and a Zacks Momentum Score of A [4][9] Company Highlights Expedia Group Inc. (EXPE) - Benefits from a strong platform model that enhances customer insights and revenue growth, with an expected revenue growth rate of 6.3% and earnings growth rate of 20.8% for next year [7][8] - Strong liquidity, share buybacks, and dividends highlight financial resilience [8] The Allstate Corp. (ALL) - Consistent growth in premiums with a 7.6% year-over-year increase in net premiums earned in the first nine months of 2025 [10][11] - Expected revenue growth rate of 5.7% and a decline in earnings by 14.5% for next year, with share repurchases totaling $805 million in the first nine months of 2025 [12][11] Dillard's Inc. (DDS) - Capturing growth in both brick-and-mortar and e-commerce, with a 1% year-over-year increase in retail sales [13][14] - Expected revenue growth rate of 0.8% and a decline in earnings by 8.2% for next year [16] Kinross Gold Corp. (KGC) - Strong production profile with a focus on organic growth through projects like the Tasiast mine, which has boosted production capacity [17][18] - Expected revenue growth rate of 6.3% and earnings growth rate of 32% for next year [19] Globus Medical Inc. (GMED) - Strengthened position in the musculoskeletal space through acquisitions, with a focus on expanding product offerings [20][21] - Expected revenue growth rate of 7.2% and earnings growth rate of 11.3% for next year [22]

Polarean’s FDA cleared coil achieves important milestone, expanding clinical reach XENOVIEW® 3T coil passes Philips compatibility testing XENOVIEW® 3T Chest Coil is now confirmed for integration with Philips MRI systems starting in 2026 DURHAM, NC and LONDON, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in advanced Magnetic Resonance Imaging ("MRI") of the lungs, announces that its FDA-cleared XENOVIEW® 3T Chest Coil has successfully complet ...