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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
Key Takeaways HOLX launched the Ultimate Defense campaign in January to promote routine Pap HPV screening.Hologic highlights Pap HPV co-testing, which offers greater sensitivity than either test alone.HOLX is expanding Genius Digital Diagnostics, using FDA-cleared AI to ease lab shortages and screening.January is observed as Cervical Cancer Awareness Month, and Hologic (HOLX) has long been a leader in cervical cancer screening. The company developed the first FDA-approved liquid-based cytology test, the Thi ...
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]