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2-DAY DEADLINE ALERT: $42.04 Stock Drop at Inspire Medical Systems (INSP) Triggers Securities Fraud Lawsuit Over Concealed Medicare Billing Software Failures & Inspire V Inventory Glut
Prnewswire· 2026-01-03 14:00
Core Viewpoint - A securities class action lawsuit has been filed against Inspire Medical Systems, Inc. (NYSE: INSP) for allegedly misleading investors regarding operational failures related to the launch of its Inspire V device for obstructive sleep apnea [1][2]. Group 1: Allegations and Impact - The lawsuit claims that Inspire Medical assured investors of its "operational readiness" for the Inspire V launch, which was later revealed to be false due to undisclosed operational issues [2][3]. - Key operational failures included delays in Medicare claims processing software updates, which did not take effect until July 1, 2025, preventing implanting centers from billing for procedures [3]. - An excess inventory of the older Inspire IV device created a channel glut, negatively impacting demand for the new Inspire V product and leading to a significant reduction in 2025 earnings per share (EPS) guidance by over 80% [3]. - Many treatment centers had not completed necessary training and onboarding for the new device, contributing to a 32.4% decline in stock value, equating to a drop of $42.04 per share [3]. Group 2: Legal Actions and Investor Guidance - Investors who purchased Inspire Medical securities between August 6, 2024, and August 4, 2025, are encouraged to contact Hagens Berman before the January 5, 2026, Lead Plaintiff Deadline to discuss their legal rights [2][4]. - Hagens Berman is focusing on the alleged concealment of critical operational issues, emphasizing that the stock collapse was due to management prioritizing a narrative over operational reality [4].
ITGR FRAUD ALERT: BFA Law Reminds Integer Holdings Corporation Investors with Losses to Contact BFA Law About the Securities Fraud Class Action
TMX Newsfile· 2026-01-03 11:18
Core Viewpoint - A class action lawsuit has been filed against Integer Holdings Corporation and certain senior executives for securities fraud following a significant drop in stock price due to alleged violations of federal securities laws [1][3]. Company Overview - Integer Holdings Corporation specializes in designing and manufacturing cardiac rhythm management and cardiovascular products, including electrophysiology devices that diagnose and treat arrhythmias [4]. Allegations of Securities Fraud - The lawsuit claims that Integer misrepresented the demand and revenue for its electrophysiology products, which had reportedly fallen sharply, contradicting the company's public statements about sales growth and market position [4][5]. Stock Price Decline - On October 23, 2025, Integer revised its 2025 sales guidance down to between $1.840 billion and $1.854 billion, significantly below analysts' expectations. The company also projected poor net sales growth of -2% to 2% and organic sales growth of 0% to 4% for 2026. This announcement led to a stock price drop of $35.22 per share, or over 32%, from $109.11 to $73.89 [6].
INSP DEADLINE MONDAY: BFA Law Reminds Inspire Medical Systems, Inc. Investors with Losses to Contact BFA Law About the Securities Fraud Class Action Before Monday's Deadline
TMX Newsfile· 2026-01-03 11:18
Core Viewpoint - A class action lawsuit has been filed against Inspire Medical Systems, Inc. and its senior executives for securities fraud following a significant drop in stock price due to alleged violations of federal securities laws [1][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the District of Minnesota, titled City of Pontiac Reestablished General Employees' Retirement System v. Inspire Medical Systems, Inc., et al., No. 0:25-cv-04247 [3]. - Investors have until January 5, 2026, to request to be appointed to lead the case [3]. Group 2: Company Background - Inspire Medical Systems develops and manufactures an implantable medical device for treating sleep apnea, with the latest version being Inspire V, which received FDA approval on August 2, 2024 [4]. Group 3: Allegations Against Inspire - The complaint alleges that Inspire misled investors by claiming it had taken necessary steps for the launch of Inspire V, while in reality, it failed to prepare clinicians and payors, leading to delays in adoption [5][6]. - The company faced weak demand for Inspire V due to customers having excess inventory of older devices [6]. Group 4: Stock Price Impact - On August 4, 2025, Inspire disclosed that the launch of Inspire V would take longer than expected, resulting in a reduction of its 2025 earnings per share guidance by over 80% [7]. - The 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].
RBC Sees Durable Growth Profile at Becton Dickinson (BDX), Raises Target
Yahoo Finance· 2026-01-02 23:21
Becton, Dickinson and Company (NYSE:BDX) is included among the 12 Best Income Stocks to Buy Now. RBC Sees Durable Growth Profile at Becton Dickinson (BDX), Raises Target On December 17, RBC Capital raised its price target on Becton, Dickinson and Company (NYSE:BDX) to $210 from $202 and kept a Sector Perform rating on the shares. The call came as part of a broader research note looking ahead to 2026 for Medical Supplies & Devices. RBC expects the sector to carry positive momentum into next year. The firm ...
CapsoVision Submits FDA 510(k) for AI-Assisted Module in CapsoCam Plus
ZACKS· 2026-01-02 18:11
Core Insights - CapsoVision, Inc. has submitted a 510(k) application to the FDA for an AI-based reading feature for its CapsoCam Plus capsule endoscopy system, aimed at improving diagnostic accuracy and workflow efficiency for clinicians [1][2] - The company believes that the integration of advanced imaging and AI models positions CapsoCam Plus as a next-generation solution for small bowel diagnostics [2] - Following the announcement, CapsoVision's shares declined by 7.7%, despite a significant increase of 205.4% over the past six months [3][8] Company Developments - The AI feature is designed to enhance the image review process, addressing lengthy review times and variability in diagnosing gastrointestinal diseases [4] - CapsoVision's market capitalization currently stands at $580.39 million [5] - The AI-assisted CapsoCam Plus aims to provide clearer images of the digestive tract, reducing the chance of missed problems and improving the experience for both doctors and patients [9][10] Technological Advancements - The AI-assisted reading module utilizes an in-house image dataset to improve diagnostic accuracy while reducing clinician workload [10] - CapsoVision's fully cloud-based system eliminates the need for on-site servers, lowering costs and maintenance requirements for GI practices [11] Industry Outlook - The capsule endoscopy market is projected to reach $479.13 million by 2025, with a CAGR of 7.95% through 2034, driven by the adoption of minimally invasive diagnostics and AI-enabled image interpretation [12] - Factors such as increasing use of capsule endoscopy in pediatric and geriatric populations and growing clinical trials for oncology screening are expected to contribute to market growth [12] Future Prospects - CapsoVision is also pursuing FDA Breakthrough Device Designation for its CapsoCam UGI capsule, aimed at early detection of pancreatic ductal adenocarcinoma [13] - The company is developing CapsoCam Colon, which will utilize advanced AI for non-invasive imaging of the colon [13]
Zacks Initiates Coverage of Iridex With Neutral Recommendation
ZACKS· 2026-01-02 15:36
Core Viewpoint - Zacks Investment Research has initiated coverage of IRIDEX Corporation (IRIX) with a Neutral recommendation, highlighting the company's strategic transformation amidst financial and operational improvements, while also noting lingering structural challenges [1] Financial Performance - Iridex has strengthened its financial foundation with a $10 million capital infusion, eliminating prior debt and increasing working capital to $11.7 million, which includes $5.6 million in cash [2] - For the first nine months of 2025, revenues increased by 5.5% to $38 million, with significant contributions from international markets, particularly the Netherlands, which accounted for nearly 16% of revenues [3] - Operating expenses decreased by 25% in the first nine months of 2025, leading to a reduction in net loss to $4.3 million from $8.1 million a year ago [4] Industry Dynamics - The demand for ophthalmic treatments is rising globally due to an aging population and increasing prevalence of chronic eye conditions, aligning with Iridex's technologies that support minimally invasive procedures [5] Challenges - Gross margin has compressed to 36.2% from 38.7%, and a $0.8 million inventory write-down in Q3 2025 indicates ongoing demand forecasting issues [6] - A 37% reduction in research and development spending may hinder innovation and competitiveness in the medtech landscape [6] - Iridex relies heavily on its distribution agreement with Topcon Corporation, which accounted for 32% of revenues, introducing concentration risk and limiting pricing flexibility [7] Market Sentiment - Iridex's share price has shown positive momentum, indicating renewed investor interest, although its valuation remains below industry norms due to execution risks and customer concentration concerns [8]
UPCOMING DEADLINE: Faruqi & Faruqi, LLP Reminds Inspire Medical Systems Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of January 5, 2026
Globenewswire· 2026-01-02 14:56
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Inspire Medical Systems, Inc. due to allegations of false and misleading statements regarding the launch of its Inspire V device, which has led to significant financial losses for investors [2][4]. Company Overview - Inspire Medical Systems, Inc. is a publicly traded company on the NYSE under the ticker INSP [2]. - The company has faced serious challenges in launching its new Inspire V device, including logistical issues and weak market demand [5][6]. Legal Proceedings - A federal securities class action has been filed against Inspire Medical, with a deadline of January 5, 2026, for investors to seek the role of lead plaintiff [2][7]. - The lead plaintiff is defined as the investor with the largest financial interest who can adequately represent the class [7]. Financial Impact - On August 4, 2025, Inspire Medical announced significant setbacks in the launch of the Inspire V device, leading to a more than 80% cut in its 2025 earnings guidance [5][6]. - Following the announcement, Inspire's stock price plummeted over 32%, from $129.95 per share to $87.91 per share, resulting in a loss of approximately $1.2 billion in market capitalization [6]. Issues with Product Launch - The company reported that the rollout of the Inspire V device was delayed due to treatment centers not completing necessary training and onboarding [5]. - Billing and reimbursement challenges were also highlighted, as Medicare's approval of a CPT code for Inspire V did not coincide with the necessary software updates for claims processing [5]. Call for Information - Faruqi & Faruqi encourages anyone with information regarding Inspire Medical's conduct, including whistleblowers and former employees, to come forward [8].
ITGR STOCK DROP: Integer Holdings Corporation Stock Plummets 32% after Weak Demand Disclosed -- Contact BFA Law about the Securities Fraud Class Action
Globenewswire· 2026-01-02 14:07
NEW YORK, Jan. 02, 2026 (GLOBE NEWSWIRE) -- Leading international securities law firm Bleichmar Fonti & Auld LLP announces that a class action lawsuit has been filed against Integer Holdings Corporation (NYSE: ITGR) and certain of the Company’s senior executives for securities fraud after a significant stock drop resulting from the potential violations of the federal securities laws. If you invested in Integer, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/int ...
INSP STOCK DROP: Inspire Medical Systems, Inc. Stock Plummets 32% after Inspire V Delays Disclosed -- Contact BFA Law about the Securities Fraud Class Action
Globenewswire· 2026-01-02 14:07
NEW YORK, Jan. 02, 2026 (GLOBE NEWSWIRE) -- Leading international 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 after a significant stock drop resulting from the potential violations of the federal securities laws. If you invested in Inspire, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/in ...
Ocumetics Technology Announces Closing of First Tranche of Brokered LIFE Offering Led by Centurion One Capital
Thenewswire· 2026-01-02 14:00
Core Viewpoint - Ocumetics Technology Corp. has successfully closed a private placement offering, raising approximately $1,023,830 through the sale of 1,706,383 units, which will be utilized for clinical trials, research and development, and general corporate purposes [1][3][4]. Group 1: Offering Details - The first tranche of the brokered private placement generated gross proceeds of about $788,380, while a concurrent non-brokered private placement added approximately $235,450, totaling around $1,023,830 [1][3]. - Each unit was priced at $0.60 and consists of one common share and one warrant, allowing the purchase of an additional common share at $0.75 until December 30, 2028 [3]. - The company incurred $143,336.17 in commissions and fees related to the offerings, with part of this amount paid in units and additional warrants issued [5]. Group 2: Use of Proceeds - The gross proceeds from the offerings are earmarked for funding the corporation's first-in-human clinical trials, ongoing research and development, and general corporate purposes, although actual allocation may vary [4]. Group 3: Related Party Transactions - Key executives and directors of the corporation participated in the private placement, qualifying it as a "Related Party Transaction" under applicable regulations, with exemptions from minority shareholder approval requirements being utilized [7].