Core Viewpoint - A class action lawsuit has been filed against Inspire Medical Systems, Inc. and certain senior executives for securities fraud following a significant stock drop due to potential violations of federal securities laws [1]. Company Overview - Inspire Medical Systems develops and manufactures an implantable medical device for the treatment of sleep apnea, with the latest version being Inspire V, which received FDA approval on August 2, 2024 [4]. Allegations and Issues - The lawsuit claims that Inspire misled investors by assuring them that all necessary steps were taken for the launch of Inspire V, which was supposed to meet high demand [5]. - Contrary to these assurances, Inspire allegedly failed to prepare clinicians and payors adequately, leading to significant delays in the device's adoption and weak demand due to customers having excess inventory of older devices [6]. Stock Performance and Impact - On August 4, 2025, Inspire disclosed that the launch of Inspire V would face an "elongated timeframe," resulting in a reduction of its 2025 earnings per share guidance by over 80% [7]. - Following this announcement, Inspire's stock price dropped by $42.04 per share, or more than 32%, from $129.95 on August 4, 2025, to $87.91 on August 5, 2025 [8].

Hangzhou, China, Dec. 29, 2025 (GLOBE NEWSWIRE) -- WORK Medical Technology Group LTD (Nasdaq: WOK) (“WORK Medical” or the “Company”), a supplier of medical devices in China, through its subsidiary, Work (Hangzhou) Medical Treatment Equipment Co., Ltd. and its subsidiaries in China, today announced that its subsidiary, Hunan Saitumofei Co., Ltd., has received manufacturing approval from the Hunan Provincial Medical Products Administration for its Class II medical device, the Artificial Intelligence (“AI”)-Au ...

NEW YORK--(BUSINESS WIRE)--Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women's health and wellness, principally in breast aesthetics and reconstruction, today announced that it has submitted Motiva® implants for approval in primary and revision breast reconstruction to the U.S. Food and Drug Administration (FDA). The products were previously approved by the FDA for use in breast augmentation on September 27, 2024. "Expanding our FD. ...

MINNEAPOLIS, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea, announced today that its management team will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026. Inspire is scheduled to present at 12:45 p.m. Eastern Time. The presentation will be accessible via a live web ...

Core Insights - Conavi Medical Corp. experienced a transformational fiscal year 2025, achieving significant regulatory, clinical, financial, and operational milestones, including the submission of its next-generation Novasight Hybrid™ system to the FDA and strengthening its balance sheet through U.S. institutional investments [2][3][6]. Business and Operational Highlights - The company completed its U.S. FDA 510(k) submission for the Novasight Hybrid™ IVUS/OCT system in September 2025, following successful validation testing with interventional cardiologists [3]. - Multiple peer-reviewed publications during fiscal 2025 emphasized the importance of intravascular imaging in complex coronary interventions, supporting Conavi's dual-modality imaging approach [4]. - Conavi participated in key cardiovascular conferences, such as TCT 2025, to showcase its hybrid imaging technology and engage with interventional cardiologists ahead of its commercial launch [5]. Financial Highlights - For the fiscal year ended September 30, 2025, Conavi reported total revenue of CAD 9.1 million, a significant increase from CAD 2.2 million in the previous year, primarily driven by licensing and milestone revenue from a technology transfer agreement in China [11]. - Operating expenses decreased to CAD 22.5 million from CAD 26.3 million in the prior year, resulting in an operating loss of CAD 14.9 million, an improvement from CAD 26.2 million in fiscal 2024 [12]. - The net loss for fiscal 2025 was CAD 20.5 million, or CAD 0.36 per share, compared to a net loss of CAD 43.6 million, or CAD 7.08 per share, in the previous year, attributed to a gain from the change in fair value of the company's warrant liability and lower operating expenses [13]. Funding and Financial Position - In April 2025, Conavi completed a public equity financing, raising CAD 20 million, and secured eligibility for up to CAD 2.5 million in non-dilutive funding from the Province of Ontario to support commercialization activities [6][14]. - As of September 30, 2025, the company reported cash and cash equivalents of CAD 5.8 million, a significant increase from CAD 0.4 million as of September 30, 2024 [14]. Market Outlook - With U.S. and European clinical guidelines now recommending the use of IVUS or OCT for guiding PCI in complex coronary interventions, Conavi is positioned to capitalize on the growing demand for intravascular imaging following anticipated FDA clearance and U.S. commercial launch [8].

格隆汇12月29日丨红日药业(300026.SZ)公布，全资孙公司天津超思医疗器械有限责任公司（简称"天津 超思"）收到天津市药品监督管理局下发的《中华人民共和国医疗器械注册证》，产品名称：多参数遥 测监护系统。 ...

Core Viewpoint - Polyrizon Ltd. is advancing its core medical pipeline while exploring investment opportunities in revenue-generating assets to enhance shareholder value [1][3]. Product Development - The company is committed to its core medical device activities, focusing on the development of products such as PL-14 (allergy blocker), PL-16 (viral blocker), and the Trap & Target platform for intranasal drug delivery [2][3]. Strategic Initiatives - The Board of Directors has authorized the exploration of investments in assets expected to generate revenues, aiming to utilize the company's resources efficiently for growth and long-term shareholder value [3]. Technology Overview - Polyrizon specializes in innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens in the nasal cavity [4]. - The proprietary Capture and Contain TM hydrogel technology is designed to function as a "biological mask" and is being further developed for enhanced bioadhesion and drug delivery [4].

Core Viewpoint - A class action lawsuit has been filed against Integer Holdings Corporation for alleged violations of securities laws, claiming the company made false statements regarding its electrophysiology devices and their impact on growth in the cardio and vascular segment [1][2]. Group 1: Lawsuit Details - The class period for the lawsuit is from July 25, 2024, to October 22, 2025, with a deadline for lead plaintiff appointments set for February 9, 2026 [2]. - The complaint alleges that Integer Holdings Corporation misled investors by claiming that its EP devices would drive long-term growth, while in reality, the company was experiencing declining sales due to market competition [2]. Group 2: Investor Participation - Shareholders who purchased shares during the class period are encouraged to contact the law firm for potential lead plaintiff appointments, although such an appointment is not necessary to participate in any recovery [2][3].

Group 1 - Butterfly Network, Inc. (BFLY) shares have doubled since the announcement of Compass AI on November 17, 2025, which aims to enhance workflows [1] - The company utilizes a novel approach for its handheld, single-probe, full-body ultrasound by leveraging semiconductors [1] Group 2 - The Busted IPO Forum focuses on stocks that have been public for 18 months to 6 years and are significantly under their offering price [1]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased common stock of Inspire Medical Systems, Inc. during the specified Class Period of the upcoming lead plaintiff deadline for a class action lawsuit [1]. Group 1: Class Action Details - Investors who bought Inspire Medical common stock between August 6, 2024, and August 4, 2025, may be eligible for compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and those wishing to serve as lead plaintiff must act by January 5, 2026 [3]. - Investors can join the class action by visiting the provided link or contacting the law firm directly for more information [6]. 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 highly in securities class action settlements, recovering hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4]. Group 3: Case Specifics - The lawsuit alleges that Inspire Medical misrepresented key facts about its sleep apnea device, Inspire V, including market demand and necessary steps for its launch, leading to misleading statements that caused investor losses when the truth was revealed [5].