Core Insights - The company reported strong third-quarter results with a revenue of $224.5 million, a 10% increase year-over-year, and reaffirmed its full-year revenue guidance of $900 to $910 million, representing a growth of 12% to 13% compared to 2024 [8][15][18] - The Inspire 5 system has shown significant clinical performance improvements, including an 87% inspiratory overlap with patient breathing and a 20% reduction in surgical times [4][5] - The company is experiencing positive feedback from clinical studies, indicating that Inspire therapy can reduce long-term cardiovascular morbidity and mortality compared to CPAP treatment [6][7] Financial Performance - Total revenue for the third quarter was $224.5 million, with U.S. revenue at $214.4 million, a 9% increase from the previous year [15] - Operating income for the quarter was $9.6 million, down from $14.3 million in the prior year, with net income at $9.9 million compared to $18.5 million [16][17] - The company increased its earnings per share guidance to 90¢ to $1, up from a previous range of 40 to 50¢ [8][19] Market and Product Development - The Inspire 5 launch is progressing well, with over 98% of physician training completed and over 75% of centers onboarding SleepSync [7][8] - The company is focusing on expanding its market access and has seen a positive trend in reimbursement, with CMS finalizing an 11% increase for CPT code 64568 [9][10] - The company is also leveraging the growing interest in sleep health driven by GLP-1 treatments, which is bringing more patients into clinics [11][12] Strategic Initiatives - The company is committed to enhancing patient outcomes through innovation and clinical evidence, with ongoing investments in medical education and patient marketing [7][13] - A new advertising campaign has been launched to promote Inspire therapy, featuring notable partnerships to increase awareness [9] - The company is actively working to transition centers from Inspire 4 to Inspire 5, with a focus on training and support for lower-volume centers [40][41] Future Outlook - The company anticipates a revenue growth of 10% to 11% for 2026, influenced by the ongoing adoption of Inspire 5 and the impact of GLP-1 treatments [22][23] - The company is monitoring competitive dynamics and expects to provide formal guidance for 2026 in January [22][58] - The company is also addressing operational efficiencies through territory management and optimizing the ratio of territory managers to field clinical representatives [77][78]

Core Viewpoint - A class action lawsuit has been filed against Dexcom, Inc. for allegedly misleading investors about the safety and reliability of its continuous glucose monitoring systems, specifically the G6 and G7 models [1][2]. Allegations - The lawsuit claims that Dexcom made unauthorized material design changes to the G6 and G7 systems, which compromised their reliability and posed health risks to users [2]. - It is alleged that Dexcom overstated the enhancements and reliability of the G7 system while downplaying the severity of issues related to adulterated devices [2]. - The complaint suggests that these actions have exposed Dexcom to increased regulatory scrutiny and potential legal repercussions [2]. Impact of Hunterbrook Report - A report published by Hunterbrook on September 18, 2025, highlighted severe health risks associated with the G7 devices, including incidents of hospitalization and death linked to inaccurate glucose readings [3]. - Following the release of this report, Dexcom's stock price dropped by $8.99 per share, or 11.76%, closing at $67.45 on September 19, 2025 [3]. Class Action Participation - Investors who purchased Dexcom securities between July 26, 2024, and September 17, 2025, may be eligible to participate in the class action, with a deadline for lead plaintiff submissions set for December 29, 2025 [4].

As filed with the U.S. Securities and Exchange Commission on November 3, 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 QT Imaging Holdings, Inc. (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code No.) Delaware 6770 85-1728920 (I.R.S. Employer Identification No.) Dr. Raluca Din ...

As filed with the U.S. Securities and Exchange Commission on November 3, 2025. Registration No. 333- FORM S-1 REGISTRATION STATEMENT UNDER UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 THE SECURITIES ACT OF 1933 QT Imaging Holdings, Inc. (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code No.) Delaware 6770 85-1728920 (I.R.S. Employer Identification No.) Dr. Raluca Din ...

Inspire Medical Systems, Inc. November 2025 NYSE: INSP Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' ''project,'' ''contemplate ...

Core Viewpoint - Sanuwave Health, Inc. will present its Q3 2025 financial results in a live conference call on November 7, 2025, at 8:30 AM (ET) [1] Company Overview - Sanuwave Health is a provider of next-generation FDA-approved wound care products, focusing on the research, development, and commercialization of patented, non-invasive medical systems for skin, musculoskeletal tissue, and vascular structure repair and regeneration [2][3] Product Portfolio - The company offers an end-to-end wound care portfolio of regenerative medicine products that aim to restore the body's normal healing processes, utilizing patented energy transfer technologies across various medical conditions including wound healing, orthopedic/spine, aesthetic/cosmetic, and cardiac/endovascular [3]

Core Insights - IR-MED Ltd. has launched its first-in-human clinical trial for the DiaSafe™ device, aimed at diabetic foot ulcer (DFU) assessment, marking a significant advancement in the field of diabetic care [1][2]. Company Overview - IR-MED Ltd. specializes in developing AI-driven, non-invasive infrared spectrographic medical devices, with a focus on improving patient outcomes through innovative technology [1][8]. - The company’s first product, PressureSafe™, is designed to assess pressure injuries and is built on the same technology platform as DiaSafe™ [8]. Clinical Trial Details - The clinical trial will be led by Prof. Aviram Nissan, a respected figure in surgical clinical research, emphasizing the collaboration's goal to enhance patient outcomes by detecting early indicators of tissue damage in diabetic patients [3]. - The DiaSafe™ device aims to provide real-time optical readings of tissue and blood biomarkers, allowing for early intervention before visible skin breakdown occurs [6]. Market Potential - The global DFU treatment market is estimated to be approximately $10 billion, highlighting the urgent need for effective solutions in this area [5][6]. - DFUs affect 19%-34% of the 537 million people living with diabetes worldwide, translating to around 183 million individuals over their lifetime, with significant risks of complications such as amputations and mortality [6].

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]