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INSP DEADLINE ALERT: Inspire Medical Systems, Inc. Investors Urged to Contact Kirby McInerney LLP About Class Action Lawsuit
Globenewswire· 2025-11-27 01:00
Core Viewpoint - Inspire Medical Systems, Inc. is facing a federal securities class action lawsuit due to allegations of misleading statements regarding the demand and launch of its implantable medical device for obstructive sleep apnea [4][5]. Group 1: Lawsuit Details - The lawsuit is on behalf of investors who purchased Inspire securities between August 6, 2024, and August 4, 2025, alleging that the company made false statements about the demand for its product and the success of its launch [4]. - Allegations include that Inspire failed to disclose poor demand for its device, as providers had surplus inventory and were hesitant to adopt the new treatment [4]. - The company admitted on August 4, 2025, that the launch of Inspire V was delayed due to incomplete training and onboarding at treatment centers, which affected billing for procedures [5]. Group 2: Financial Impact - Following the announcement of the launch issues and reduced earnings guidance by over 80%, Inspire's share price dropped by $42.04, or approximately 32.35%, from $129.95 to $87.91 on August 5, 2025 [5].
DXCM DEADLINE ALERT: ROSEN, A LONGSTANDING AND TRUSTED FIRM, Encourages DexCom, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action - DXCM
Newsfile· 2025-11-27 00:15
Core Viewpoint - The Rosen Law Firm is reminding investors of DexCom, Inc. about an important deadline related to 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]. - The lawsuit alleges that DexCom made unauthorized design changes to its G6 and G7 continuous glucose monitoring systems, which rendered them less reliable and posed health risks to users [5]. - The defendants are accused of making false statements regarding the reliability and functionality of the G7 devices, leading to increased regulatory scrutiny and potential legal repercussions for DexCom [5]. Group 2: Legal Representation - Investors are encouraged to select qualified legal counsel with a proven track record in securities class actions, as many firms may lack the necessary experience and resources [4]. - The Rosen Law Firm has a history of successful settlements in securities class actions, having recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4]. - To join the class action, investors can visit the provided link or contact the firm directly for more information [3][6].
Recent Market Trends Highlight Top Gainers Across Various Sectors
Financial Modeling Prep· 2025-11-27 00:00
Company Highlights - Zynex, Inc. (NASDAQ:ZYXI) experienced a 98% increase in stock price, reaching $1.46 from a low of $0.695, with a trading volume exceeding 66 million shares, driven by strong Q3 results [1][6] - Pasithea Therapeutics Corp. (KTTA) saw a 69.4% rise in stock price to $0.826, peaking at $1.34 during the day, with a trading volume of approximately 124 million shares, following a $1 million grant from the ALS Association for ALS research [2][6] - Amber International Holding Ltd (Nasdaq: AMBR) reported a 59.49% jump in stock price to $2.52, with over 85 million shares traded, and announced a $50 million share repurchase program, reflecting strong business momentum [3][6] - SMX (NASDAQ:SMX) saw its stock price climb by 58.21% to $9.35, with over 12 million shares traded, showcasing strong momentum at the 2025 DMCC Precious Metals Conference [4][6] Market Trends - The market is characterized by significant investor interest and stock price volatility across various sectors, including healthcare, biotechnology, real estate, and technology, driven by company-specific developments and broader market trends [5]
ROSEN, RECOGNIZED INVESTOR COUNSEL, Encourages Tandem Diabetes Care, Inc. Investors to Inquire About Securities Class Action Investigation - TNDM
Newsfile· 2025-11-26 22:03
Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Tandem Diabetes Care, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Legal Action and Investor Rights - Shareholders who purchased Tandem Diabetes Care securities may be entitled to compensation through a class action lawsuit without any out-of-pocket fees [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to the misleading information [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 that could lead to insulin delivery discontinuation [3]. - Following this announcement, Tandem Diabetes' stock experienced a significant decline of 19.9% 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]. - In 2019, the firm secured over $438 million for investors, showcasing its capability in recovering substantial amounts for clients [4].
Anteris Technologies Global Corp(AVR) - Prospectus
2025-11-26 21:35
ANTERIS TECHNOLOGIES GLOBAL CORP. (Exact name of registrant as specified in its charter) TABLE OF CONTENTS As filed with the Securities and Exchange Commission on November 26, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 3842 99-1407174 (I.R.S. Employer Identific ...
Beyond Air® Announces Transition of Chief Financial Officer
Globenewswire· 2025-11-26 21:30
Core Points - Doug Larson has resigned as Chief Financial Officer of Beyond Air, Inc. to pursue another opportunity, with an interim CFO to be appointed [1][4] - Larson's leadership was crucial in transitioning Beyond Air to a commercial business, particularly with the launch of LungFit PH and clinical research subsidiaries [2] - Beyond Air is actively searching for a permanent successor for the CFO position [1] Company Overview - Beyond Air, Inc. is a commercial-stage medical device and biopharmaceutical company focused on using nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors [5] - The company has received FDA approval and CE Mark for its LungFit PH system, aimed at treating neonates with hypoxic respiratory failure [5][9] - Beyond Air is advancing other LungFit systems in clinical trials for severe lung infections, including COVID-19 [5][8] Product Details - LungFit is a cylinder-free, phasic flow generator that delivers nitric oxide at concentrations from 1 ppm to 80 ppm, offering operational advantages in hospital settings [7] - The system is designed to replace high-pressure nitric oxide cylinders, improving safety and reducing storage requirements [7] - Beyond Air aims to provide nitric oxide treatment in home settings, particularly for chronic lung infections [8] Research and Development - Beyond Air has partnered with The Hebrew University of Jerusalem to develop treatments for autism spectrum disorder and other neurological disorders [6] - Beyond Cancer, an affiliate of Beyond Air, is investigating the use of ultra-high concentrations of nitric oxide for targeting solid tumors [12] - NeuroNOS, another affiliate, focuses on therapies for neurodevelopmental and neurodegenerative disorders by regulating nitric oxide levels in the brain [13]
Orchestra BioMed Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-11-26 21:05
Core Insights - Orchestra BioMed Holdings, Inc. has granted stock options to 12 newly hired employees, totaling 151,250 shares, as part of its 2025 New Hire Inducement Plan [1][2] - The stock options will vest 25% on the first anniversary of employment, with the remainder vesting quarterly over three years [2] Company Overview - Orchestra BioMed is focused on accelerating high-impact biomedical technologies through partnerships with leading global medical device companies [3] - The company's flagship products include Atrioventricular Interval Modulation (AVIM) Therapy for hypertension and Virtue Sirolimus AngioInfusion™ Balloon (Virtue SAB) for atherosclerotic artery disease, both targeting multi-billion-dollar market opportunities [3] - AVIM Therapy aims to provide significant blood pressure reduction in patients with hypertensive heart disease and has FDA Breakthrough Device Designation [3] - Virtue SAB is a novel drug delivery system for treating coronary ISR, small vessel disease, and below-the-knee peripheral artery disease, also granted Breakthrough Device Designation by the FDA [3]
New Clinical Evidence Bolsters Hologic's Breast Cancer Technologies
ZACKS· 2025-11-26 14:21
Core Insights - Artificial intelligence (AI) is becoming essential in mammography, with the global AI in breast imaging market projected to grow at a CAGR of 3.30% through 2034, driven by increasing breast cancer prevalence and technological advancements [1] Company Developments - Hologic is committed to advancing technologies in breast health, with real-world studies being crucial for its development [1] - At the upcoming RSNA 2025 Annual Meeting, Hologic will present new data on its breast cancer detection technologies, including the 3DQuorum imaging technology that utilizes AI to optimize the review process for radiologists [2] - A retrospective study involving over 160,000 screening mammography exams indicated that the adoption of 3DQuorum did not significantly alter cancer detection rates, suggesting its potential to enhance workflow efficiency for radiologists [3] - In a separate study, Hologic's Genius AI Detection solution performed comparably to radiologists in detecting challenging breast cancer cases, although it exhibited lower specificity, leading to more false positives [4] - Hologic plans to showcase its AI-powered Genius AI Detection suite, advanced breast surgery technologies, and the next-generation Envision Mammography Platform at RSNA, with the latter set to launch commercially in fiscal 2026 [5] Industry Context - QIAGEN N.V. introduced the QIAsymphony Connect, enhancing its automated nucleic acid purification platform to support liquid biopsy applications [6] - GE Healthcare launched the Genesis Radiology Workspace, aimed at transforming radiology workflows and improving efficiency for radiologists [7] Stock Performance and Valuation - Year-to-date, Hologic shares have increased by 3.8%, compared to the industry's growth of 4.5% [8] - Hologic's forward five-year price-to-sales (P/S) ratio stands at 3.86X, which is lower than the industry average of 4.40X [10]
Inspire Medical (INSP) Faces Securities Class Action Over Claims It Misled Investors on Next-Generation Device Launch -- Hagens Berman
Prnewswire· 2025-11-26 13:50
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][5]. Company Overview - Inspire Medical Systems, Inc. specializes in implantable neurostimulation technology aimed at improving respiration during sleep [3]. Legal Proceedings - 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 [2][6]. - The lead plaintiff deadline for the lawsuit is set for January 5, 2026 [2]. Allegations - The complaint alleges that the company misrepresented the transition to the Inspire V device as seamless, while in reality, it faced significant operational challenges [3][6]. - Key allegations include poor market demand, incomplete readiness for the launch, and undisclosed logistical issues that hindered the rollout of the Inspire V device [8]. Market Reaction - On August 4, 2025, Inspire Medical publicly acknowledged that the launch of the Inspire V device was facing an "elongated timeframe," leading to a drastic reduction in 2025 earnings guidance by over 80% [4][5]. - Following this announcement, the company's stock price plummeted by over 32% on heavy trading volume [5]. Investigation Focus - Hagens Berman is investigating potential misstatements or omissions related to the Inspire V device launch and its financial implications [7]. - The investigation is particularly focused on whether management was aware of critical operational flaws, such as billing code delays and training deficiencies, prior to the public disclosure [9].
Autonomix Medical, Inc. (NASDAQ: AMIX) Announces Release of the Next CEO Corner Segment Highlighting Continued Execution and Strategic Growth
Globenewswire· 2025-11-26 13:45
Core Insights - Autonomix Medical, Inc. is focusing on advancing precision nerve-targeted treatments and has published a CEO Corner segment discussing its strategic direction [1] - The company aims to protect its platform's strength through intellectual property and is exploring new opportunities beyond pancreatic cancer into cardiovascular, pulmonary, and chronic pain areas [1] Company Overview - Autonomix is a medical device company dedicated to innovative technologies for diagnosing and treating diseases of the nervous system [3] - The company's platform technology includes a catheter-based microchip sensing array designed to detect and differentiate neural signals with greater sensitivity than existing technologies [3] - This technology aims to enable transvascular diagnosis and treatment of peripheral nervous system diseases across the body [3] Current Development Focus - The initial development of the technology is targeted at pain management, specifically for pancreatic cancer, which is known for causing severe pain and lacks reliable treatment options [4] - The technology serves as a platform for addressing multiple indications, including cardiology, hypertension, and chronic pain management [4] - The technology is currently investigational and has not yet received marketing clearance in the United States [4]