Core Viewpoint - A class action lawsuit has been filed against DexCom, Inc. and its senior executives for securities fraud following significant stock declines attributed to potential violations of federal securities laws [1][2]. Company Overview - DexCom manufactures continuous glucose monitoring (CGM) systems, including the Dexcom G6 and G7, which were marketed as highly accurate devices [3]. Allegations - The lawsuit alleges that DexCom made unauthorized design changes to the G6 and G7, compromising their accuracy and exposing customers to serious health risks while prioritizing cost reduction over safety [4]. Stock Performance - DexCom's stock experienced notable declines due to revelations about product quality issues: - On March 7, 2025, the stock fell by $7.12 per share (over 9%) following an FDA warning letter regarding manufacturing concerns [5]. - After the FDA's public disclosure on March 25, 2025, the stock dropped another $3.19 per share (over 4%) [6]. - A report published on September 18, 2025, indicated severe safety issues, leading to a nearly 12% decline of $8.99 per share over two trading days [7].

[Music] Stocks our strategists feel are poised to deliver positive returns are featured now in their top stock picks of the week. Welcome to today's top stock pick. I am Jeremy Mullen along with Ian Feller who will have his pick shortly.But first, we'll be doing Intuitive Surgical, ticker symbol ISRG. Intuitive makes robotic surgery systems that help doctors perform minimally invasive procedures. Their flagship product is the Da Vinci robot, which gives surgeons better vision, control, and precision than tr ...

Core Viewpoint - A class action securities lawsuit has been filed against Baxter International, Inc. due to alleged securities fraud affecting investors between February 23, 2022, and July 30, 2025 [1] Group 1: Allegations of Fraud - The lawsuit claims that Baxter's Novum LVP product had systemic defects leading to malfunctions such as underinfusion, overinfusion, and non-delivery of fluids, posing serious risks to patients [2] - It is alleged that Baxter was aware of multiple device malfunctions, injuries, and deaths related to these defects [2] - Baxter's attempts to address these issues through customer alerts were deemed inadequate, as design flaws persisted and continued to harm patients [2] - The lawsuit suggests that there was an increased risk of customers being instructed to take existing Novum LVPs out of service and that Baxter would halt all new sales of these pumps [2] - Baxter's statements regarding the safety, efficacy, product rollout, customer feedback, and sales prospects of the Novum LVPs were claimed to be materially false and misleading [2] Group 2: Legal Process and Participation - Investors who suffered losses during the specified timeframe have until December 15, 2025, to request to be appointed as lead plaintiff, although participation in any recovery does not require serving as a lead plaintiff [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees, with no obligation to participate [3] Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has extensive expertise in complex securities litigation [4] - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the United States [4]

Core Insights - TELA Bio, Inc. has appointed William Plovanic, CFA, to its Board of Directors, enhancing its leadership with expertise in capital markets and medical technology operations [1][3]. Group 1: Appointment Details - William Plovanic brings over 25 years of experience in capital markets, corporate strategy, and medical device operations [4][5]. - He currently serves as Managing Director of Healthcare Equity Research at Canaccord Genuity and has held C-level roles at Obalon Therapeutics from 2016 to 2021 [2][5]. Group 2: Company Strategy and Vision - TELA Bio focuses on innovative soft-tissue reconstruction solutions that prioritize the preservation and restoration of the patient's anatomy [7]. - The company aims to provide advanced, economically effective solutions that leverage the patient's natural healing response while minimizing long-term exposure to synthetic materials [7]. Group 3: Leadership Perspective - The CEO of TELA Bio, Antony Koblish, expressed confidence that Plovanic's experience will strengthen the company's strategy and drive long-term shareholder value [3]. - Plovanic stated his honor in joining TELA Bio at a pivotal stage, highlighting the company's leadership in redefining soft-tissue reconstruction [3].

MINNEAPOLIS, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (“Tactile Medical”; the “Company”) (Nasdaq: TCMD), a medical technology company providing therapies for people with chronic disorders, today reported financial results for the third quarter ended September 30, 2025 and announced the adoption of a second share repurchase program. Third Quarter 2025 Summary & Recent Business Highlights: Total revenue increased 17% year-over-year to $85.8 millionGross margin of 76% versus 75% in Q3 ...

Core Insights - Inspire Medical Systems reported strong financial results for Q3 2025, with a focus on the transition to the Inspire V system and positive global performance [3][4]. Recent Business Highlights - The company presented clinical evidence at industry meetings showing that the Inspire V system has enhanced performance compared to legacy systems [3]. - A successful device implant rate of 100% was reported in studies conducted in Singapore and the U.S. [3]. - The Inspire V system demonstrated a 20% reduction in surgical procedure time and significant reductions in disease severity [3]. - Over 75% of centers are ready to transition to the Inspire V system, indicating strong progress in the U.S. launch [3]. Third Quarter 2025 Financial Results - Revenue for Q3 2025 was $224.5 million, a 10% increase from $203.2 million in Q3 2024 [4]. - U.S. revenue was $214.4 million, up 9% year-over-year, while international revenue reached $10.1 million, a 37% increase [4]. - Gross margin improved to 85.8% from 84.1% in the prior year, attributed to higher sales volume and a favorable sales mix [5]. Operating Expenses and Income - Operating expenses rose to $183.1 million, a 17% increase from $156.5 million in Q3 2024, mainly due to marketing and corporate costs [6]. - Operating income decreased to $9.6 million from $14.3 million in the prior year [7]. Net Income and Earnings Per Share - Net income for Q3 2025 was $9.9 million, down from $18.5 million in Q3 2024 [8]. - Diluted net income per share was $0.34, compared to $0.60 in the prior year [8]. Full Year 2025 Guidance - The company maintains its revenue guidance for 2025 at $900 million to $910 million, reflecting a growth of 12% to 13% over 2024 [11]. - Gross margin guidance remains at 84% to 86%, with an increased diluted net income per share guidance of $0.90 to $1.00 [11]. Cash Position - As of September 30, 2025, cash, cash equivalents, and investments totaled $410.9 million, down from $516.5 million at the end of 2024 [10]. Share Repurchase - The company completed a $50 million share repurchase, indicating confidence in its financial position [9].

Acquisition - Hologic entered into an agreement to be acquired by Blackstone and TPG for $76 per share in cash plus a contingent value right of up to $3 per share, potentially reaching $79 per share[13] - The acquisition is expected to close in the first half of calendar year 2026[13] Financial Performance - Hologic's Q4'25 GAAP revenue was $1,049.5 million, a 6.2% increase compared to Q4'24[68] - Q4'25 Non-GAAP revenue was also $1,049.5 million, with organic revenue at $1,027.7 million and organic revenue excluding COVID at $998.6 million[69] - Hologic's GAAP diluted EPS for Q4'25 was $0.83, a 9.2% increase[68] - Non-GAAP diluted EPS for Q4'25 was $1.13, an 11.9% increase[69] - The company's net debt to adjusted EBITDA leverage ratio is 0.4x[59, 111] Segment Performance - Diagnostics revenue in Q4'25 was $454.1 million[70] - Breast Health revenue in Q4'25 was $393.7 million[70] - GYN Surgical revenue in Q4'25 was $172.5 million[70] - Skeletal Health revenue in Q4'25 was $29.2 million, a 128.1% increase[70]

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Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Baxter International Inc. due to allegations of federal securities law violations related to the Novum LVP device malfunctions, which have reportedly caused serious risks to patients [2][4]. Group 1: Allegations and Impact - The complaint alleges that Baxter and its executives made false or misleading statements regarding the Novum LVP, failing to disclose systemic defects that led to malfunctions, including underinfusion and overinfusion, posing risks of serious injury or death to patients [4]. - Baxter was reportedly aware of multiple device malfunctions, injuries, and deaths but did not take adequate remedial measures, leading to a heightened risk of customers removing the Novum LVPs from service and pausing new sales [4]. - Following the announcement on July 31, 2025, regarding the voluntary pause of shipments and installations of the Novum LVP, Baxter's stock price fell by 22.4%, closing at $21.76 [5]. Group 2: Legal Proceedings - Investors who suffered losses exceeding $100,000 in Baxter between February 23, 2022, and July 30, 2025, are encouraged to contact Faruqi & Faruqi to discuss their legal rights and options [1][2]. - The deadline for investors to seek the role of lead plaintiff in the federal securities class action against Baxter is December 15, 2025 [2][6]. - Faruqi & Faruqi is also inviting anyone with information regarding Baxter's conduct, including whistleblowers and former employees, to come forward [6].

Core Insights - Merit Medical Systems, Inc. announced 24-month efficacy findings from the non-randomized AVG cohort of the WAVE trial, showcasing the performance of the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE) for patients with advanced kidney disease undergoing hemodialysis [1][5][6] Group 1: Trial Overview - The WAVE trial aimed to evaluate the performance of the WRAPSODY CIE in restoring functional vascular access in patients with complications such as stenosis or occlusion [3] - The trial involved 43 centers across the United States, South America, and the United Kingdom [3] Group 2: Efficacy Results - In the non-randomized arm of the WAVE trial, 112 patients were treated with the WRAPSODY CIE, achieving a target lesion primary patency (TLPP) of 81.4% at 6 months, exceeding the established performance goal of 60% [4] - The TLPP at 12 months was 60.2%, and at 24 months, it was 41.7% [4][10] - The access circuit primary patency (ACPP) at 12 months was 36.2%, and at 24 months, it was 25.7% [4][10] Group 3: Regulatory Approvals - The WRAPSODY CIE received premarket approval from the US FDA on December 19, 2024, and was approved by Health Canada on April 30, 2025 [6] - The device has also received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil [6] Group 4: Future Research - Real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America Registry, which aims to enroll up to 250 patients [8]