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Medtronic Diabetes expands access to full-stack insulin delivery solutions with Medicare access and new FDA clearances
Prnewswire· 2026-02-02 14:17
GALWAY, Ireland, Feb. 2, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced three significant U.S. milestones that expand access, choice, and flexibility for people living with type 1 and insulinrequiring type 2 diabetes. These milestones include Medicare access for the MiniMedâ"¢ 780G system paired with the Instinct sensor, made by Abbott, FDA clearance for the system's use with ultra rapidacting insulins, and clearance of the MiniMedâ"¢ 780G system for us ...
Hologic Leads Campaign to Emphasize Routine Cervical Cancer Screening
ZACKS· 2026-01-16 13:20
Core Insights - January is recognized as Cervical Cancer Awareness Month, with Hologic being a leader in cervical cancer screening through innovations like the ThinPrep Pap test and the Aptima HPV Assay. Co-testing with both tests shows higher sensitivity for cervical cancer detection than using either test alone [1][9]. Industry Overview - The global HPV testing and Pap test market was valued at $6.18 billion in 2024, with a projected CAGR of 7.2% through 2033. Despite cervical cancer being largely preventable, incidence rates are rising due to missed screenings, necessitating a comprehensive approach that includes awareness and patient education [2]. Company Initiatives - Hologic emphasizes the importance of Pap + HPV screening through partnerships with healthcare professionals and advocates. The company launched the Ultimate Defense campaign featuring Erica Wheeler to raise awareness about routine cervical cancer screening [3][9]. - In 2024, Hologic introduced Genius Digital Diagnostics, the first FDA-cleared digital cytology system that utilizes AI to identify pre-cancerous lesions and cervical cancer cells [4]. - The expansion of the Genius Digital Diagnostics platform aims to address labor shortages and improve screening capabilities in regions with limited infrastructure, contributing to the company's growth over the next several quarters [5]. Competitive Landscape - Boston Scientific has agreed to acquire Penumbra for approximately $14.5 billion, aiming to enhance its cardiovascular portfolio and address vascular disease prevalence [6]. - Medtronic received FDA clearance for its MiniMed Go app, a smart diabetes management solution, with a commercial launch expected in spring 2024 [7]. Financial Performance - Hologic shares have increased by 17.2% over the past six months, outperforming the industry growth of 10.6% [8]. - The company is trading at a forward five-year price-to-sales (P/S) ratio of 3.85X, which is lower than its median and the industry average of 4.18X [10]. Earnings Estimates - Current earnings estimates for Hologic indicate a projected EPS of 1.09 for Q4 2025 and 4.50 for the fiscal year 2026, with stable estimates over the past 30 days [12].
Medtronic Diabetes announces FDA clearance for MiniMed Go™ Smart MDI system featuring Instinct sensor made by Abbott
Prnewswire· 2026-01-12 14:00
Core Insights - Medtronic has received FDA 510(k) clearance for its MiniMed Go™ Smart MDI system, which integrates insulin dosing and glucose data into a single app, aimed at improving diabetes management for individuals on multiple daily injections [1][2]. Product Overview - The MiniMed Go™ system combines the InPen™ smart insulin pen and Abbott's Instinct sensor, providing real-time glucose data, dose calculations, missed dose alerts, and actionable guidance [9]. - The system is designed for individuals aged 7 years and older with insulin-requiring type 1 and type 2 diabetes, and for children aged 2 to 6 under adult supervision [2]. Market Need - Over 15 million people globally rely on multiple daily injections for diabetes management, often facing challenges during mealtimes that can lead to diabetes distress [3]. - Missed boluses can significantly affect diabetes management, with just two missed doses a week potentially raising HbA1C levels by up to 0.4%, increasing the risk of complications [4]. Performance Data - Previous users of Medtronic's Smart MDI system experienced improvements in glycemic control, with Time in Range (TIR) increasing from 55.7% to 67.2% when responding to over 75% of missed dose alerts within an hour [5]. Company Vision - Medtronic aims to simplify diabetes management for individuals using injections by providing the benefits of automated insulin delivery systems, thereby reducing the burden of daily insulin dosing [6]. Features and Benefits - The MiniMed Go™ system includes missed dose alerts, a dose calculator for easier decision-making, action-oriented guidance for missed or miscalculated doses, and CareLink™ software for enhanced provider collaboration [7]. Launch Timeline - The commercial launch of the MiniMed Go™ system is expected to begin in the U.S. in the spring of 2026 [8]. Company Background - Medtronic is a leading global healthcare technology company focused on innovative solutions for various health conditions, including diabetes management, with a commitment to enhancing patient outcomes through advanced technology [12].
MDT Stock Set to Benefit From the FDA Clearance of Hugo RAS System
ZACKS· 2025-12-05 14:51
Core Insights - Medtronic plc (MDT) has received FDA approval for the Hugo robotic-assisted surgery (RAS) system, enhancing urologic surgical procedures and providing a versatile platform for minimally invasive care [1][9]. Company Developments - The Hugo RAS system builds on Medtronic's existing surgical offerings, including the Touch Surgery ecosystem, to create a connected operating room environment [2]. - Following the announcement on December 3, MDT shares increased by 0.02%, closing at $101.99, indicating a positive market reaction [3]. - Medtronic's current market capitalization stands at $130.73 billion, with an earnings yield of 5.5%, significantly higher than the industry average of 0.1% [4]. Product Features - The Hugo RAS system features a modular design that allows for flexible deployment across various care settings, enhancing utilization and customization for surgeons [5]. - The system includes an open surgeon console that improves situational awareness, reduces physical strain, and offers better training opportunities for surgical teams [5][6]. - It integrates with the Touch Surgery ecosystem, providing pre-operative training, remote tele-proctoring, and AI-driven post-operative insights, making Medtronic the only company to support all surgical modalities [6]. Market Potential - The global urology robotic surgery market is valued at $2 billion in 2024, with a projected CAGR of 8.7% through 2033, driven by the demand for minimally invasive surgeries [10]. - Medtronic plans to expand the Hugo RAS system's applications in the U.S. to include general and gynecologic surgical procedures following its initial urology clearance [7]. Stock Performance - Over the past six months, MDT shares have increased by 16.6%, outperforming the industry, which saw a decline of 1.3% [12].
Hologic's BCI Test Shows Growing Impact in Endocrine Therapy Decisions
ZACKS· 2025-12-04 16:26
Core Insights - Hologic's acquisition of Biotheranostics in 2021 has significantly enhanced its position in the oncology sector, which is characterized by rapid growth and higher profit margins compared to its traditional service offerings [2] - The Breast Cancer Index (BCI) test, developed by Biotheranostics, is the only test endorsed by major clinical guidelines for predicting the benefits of extended endocrine therapy in early-stage, HR+ breast cancer patients, although it has not received FDA approval [2] - Hologic and Biotheranostics will present 11 studies at the 2025 San Antonio Breast Cancer Symposium, focusing on the BCI test's expanded utility and consistent performance across various patient demographics [3] Business Performance - Biotheranostics has contributed positively to Hologic's Molecular Diagnostics business, with ongoing growth driven by increased adoption and coverage of the BCI test [5] - An analysis presented at the 2025 American Society of Clinical Oncology Annual Meeting indicated that BCI testing altered treatment recommendations in approximately 40% of cases among over 2,800 patients, enhancing physician confidence and patient comfort regarding treatment decisions [4] Competitive Landscape - Medtronic has received FDA clearance for its Hugo robotic-assisted surgery system, expanding options for urologic surgical procedures [6] - Becton, Dickinson and Company has launched new cell analyzers with advanced imaging technologies, facilitating research in immunology and cancer therapy [7] Stock Performance and Valuation - Hologic's stock has increased by 18.9% over the past six months, outperforming the industry average growth of 14% [8] - The company is currently trading at a forward five-year price-to-sales ratio of 3.87X, which is lower than the industry average of 4.39X [10] Earnings Projections - Analysts project Hologic's earnings for fiscal years 2025 and 2026 to be $4.50 and $4.96 per share, respectively, with current quarter estimates at $1.09 [12]
Medtronic begins U.S. commercial launch of the MiniMed™ 780G system with the Instinct sensor, made by Abbott
Prnewswire· 2025-12-02 14:00
Core Insights - Medtronic has launched the MiniMed™ 780G system integrated with Abbott's Instinct sensor in the U.S., marking a significant advancement in diabetes management technology [1][2][3] Product Launch - The MiniMed™ 780G system is now commercially available following FDA clearance, allowing for integration with the Instinct sensor [1][2] - The Instinct sensor is noted for being the world's smallest and thinnest continuous glucose monitor (CGM), with a wear time of up to 15 days [3][6] Technology Features - The MiniMed™ 780G system automates insulin adjustments every five minutes based on real-time glucose readings, which helps users manage diabetes more effectively [3][6] - The combination of the Instinct sensor and the MiniMed™ 780G system has received positive feedback from early users, indicating improved time in glucose range for patients [4][5] Market Positioning - The launch of the Instinct sensor expands Medtronic's sensor portfolio, which includes the recently launched Simplera Sync™ sensor and the Guardian™ 4 sensor, enhancing the company's offerings in diabetes care [4][5] - Medtronic aims to provide a personalized diabetes management experience, allowing users to choose solutions that best fit their lifestyles [5][7] Company Mission - Medtronic's mission is to make diabetes management more predictable and to improve the quality of life for individuals living with diabetes through advanced technology and support [7][8]
Medtronic's Q2 Earnings & Revenues Beat Estimates, Stock Climbs
ZACKS· 2025-11-18 15:36
Core Insights - Medtronic plc (MDT) reported second-quarter fiscal 2026 adjusted earnings per share (EPS) of $1.36, a 7.9% increase year-over-year, exceeding the Zacks Consensus Estimate by 3.82% [1] - The company's worldwide revenues for the quarter reached $8.96 billion, reflecting a 6.6% year-over-year increase and surpassing the Zacks Consensus Estimate by 1.11% [2] Revenue Breakdown - MDT's revenues are categorized into four segments: Cardiovascular, Medical Surgical, Neuroscience, and Diabetes [3] - Cardiovascular revenues grew 9.3% organically to $3.44 billion, with Cardiac Rhythm & Heart Failure sales increasing 14.3% year-over-year to $1.83 billion [4][5] - Medical Surgical sales totaled $2.17 billion, up 1.3% year-over-year, with Surgical & Endoscopy revenues at $1.68 billion, a 1.1% increase [5] - Neuroscience revenues reached $2.56 billion, a 3.9% year-over-year increase, with Neuromodulation revenues growing 7.3% to $520 million [6] - Diabetes segment revenues rose 7.1% organically to $757 million [6] Margin Performance - The gross margin expanded by 90 basis points to 65.8%, despite a 3.9% increase in the cost of products sold [7] - Research and development expenses increased by 8.2% year-over-year to $754 million, while selling, general, and administrative expenses rose 7.5% to $2.97 billion [7] - The adjusted operating margin improved by 50 basis points year-over-year to 24.3% [7] Fiscal 2026 Outlook - Medtronic raised its fiscal 2026 organic revenue growth projection to 5.5% from approximately 5% [10] - The company expects full-year adjusted EPS in the range of $5.62-$5.66, up from the previous range of $5.60-$5.66 [10] - The Zacks Consensus Estimate for fiscal 2026 worldwide revenues is $35.83 billion [10] Strategic Developments - The quarter marked the strongest Cardiovascular revenue growth in over a decade, excluding the pandemic [11] - Medtronic received FDA approval for the Altaviva device and the MiniMed 780G system, enhancing its product offerings [11] - The company anticipates further revenue growth acceleration driven by several enterprise growth drivers, including new therapies and technologies [12]
Abbott Gains Diabetes Tech Expansion Opportunity Following Earnings Beat and Insider Sale
Yahoo Finance· 2025-10-01 21:28
Core Insights - Abbott Laboratories (NYSE:ABT) is recognized as one of the 12 Set-It-and-Forget-It Stocks to buy now, driven by a positive second quarter performance and an executive sale, alongside an expansion opportunity from Medtronic [1] Financial Performance - Abbott reported a 6.9% increase in sales for Q2 2025, with an Adjusted EPS of $1.26, surpassing consensus estimates [2] - The company is progressing in its biosimilars portfolio and expects multiple launches in 2026 [2] Executive Activity - Following the Q2 results, Philip P Boudreau, Executive Vice President and CFO, sold 5,550 shares valued at $746,752 on August 11, 2025, indicating potential negative sentiment [3] Market Opportunities - The FDA cleared Medtronic's MiniMed 780G system on September 2, 2025, which integrates with Abbott's Instinct sensor, providing an opportunity for expansion in diabetes technology [3] Company Overview - Abbott Laboratories has a significant market capitalization of $232.44 billion, establishing a strong presence in the healthcare industry [4] - The company, headquartered in Illinois and operational since 1888, develops and sells a diverse range of medical devices, diagnostics, nutritional products, and branded generic pharmaceuticals globally [4]
Medtronic Receives FDA Nod for Altaviva Device: Stock to Gain?
ZACKS· 2025-09-24 14:01
Core Insights - Medtronic plc (MDT) has received FDA approval for the Altaviva device, a minimally invasive implantable tibial neuromodulation therapy aimed at treating urge urinary incontinence, marking a significant advancement in bladder control therapies [1][9] - The introduction of the Altaviva device positions MDT as the only company with a comprehensive portfolio of neuromodulation therapies for bladder control symptoms, which is expected to enhance revenue growth and improve stock performance [3][4] Company Developments - The Altaviva device features a 15-year battery life, quick recharging capabilities, and is MRI-compatible, making it a patient-friendly option for those suffering from urge urinary incontinence [6][9] - Medtronic's market capitalization stands at $121.80 billion, with a projected revenue growth of 6.8% for fiscal 2026 compared to fiscal 2025 [4] - The company has consistently outperformed earnings expectations in the past four quarters, with an average surprise of 2.20% [4] Industry Context - Bladder control issues affect approximately 43 million U.S. adults, with nearly 16 million experiencing urge urinary incontinence, indicating a substantial market for the Altaviva device [10] - The global urinary incontinence therapeutics market is expected to grow at a CAGR of 4.0% from 2024 to 2030, driven by an aging population and increased awareness [10]
Medtronic plc (MDT) Announces FDA Approval for SmartGuard Algorithm as Automated Glycemic Controller
Yahoo Finance· 2025-09-10 08:53
Core Insights - Medtronic plc has received FDA approval for its SmartGuard algorithm as an interoperable automated glycemic controller, which integrates with Abbott's Instinct sensor for type 1 diabetes [2] - The MiniMed 780G system has also been approved for adults with insulin-requiring type 2 diabetes, marking a significant advancement in automated insulin delivery systems [3] - Clinical trials supporting these products indicate improved HbA1c levels, greater time in range, and reduced diabetes distress for patients [3] Company Developments - The collaboration with Abbott aims to create a smarter dosing ecosystem to enhance daily management and improve the quality of life for diabetes patients [4] - Medtronic is recognized as a global healthcare technology leader, providing innovative therapies and devices for over 70 health conditions [4] Market Position - Despite the advancements and potential of Medtronic, it is listed among stocks recommended for sale, indicating a cautious outlook from some analysts [1][4] - There is a suggestion that certain AI stocks may offer better investment opportunities with higher upside potential and lower downside risk compared to Medtronic [5]