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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]
MDT Stock May Benefit From New Regulatory Wins for Its MiniMed 780G
ZACKS· 2025-09-05 13:50
Core Insights - Medtronic plc (MDT) has achieved two significant regulatory milestones for its MiniMed 780G system, including FDA clearance for the SmartGuard algorithm and approval for use in adults with insulin-requiring type 2 diabetes [1][9]. Regulatory Achievements - The FDA has cleared the SmartGuard algorithm as an interoperable automated glycemic controller, allowing integration with Abbott's Instinct sensor for type 1 diabetes [1][5]. - The MiniMed 780G system is now approved for adults aged 18 and above with insulin-requiring type 2 diabetes, making it the first AID system with Meal Detection technology for this demographic [7][9]. Market Performance and Growth - Following the announcement, MDT shares experienced a slight decline of 1.2%, closing at $92.25 [3]. - The Diabetes business is growing above the company average, driven by the MiniMed 780G system and Simpler Sync sensor in international markets [3]. - Medtronic has a market capitalization of $118.33 billion, with a projected revenue growth of 6.8% for fiscal 2026 compared to fiscal 2025 [4]. Product Integration and Future Plans - The Instinct sensor, designed by Abbott, is the world's smallest integrated CGM, with a wear time of up to 15 days, and will be integrated with the MiniMed 780G system [5][6]. - Medtronic and Abbott are finalizing compliance documentation for sensor integration, with pre-orders for the Simplera Sync sensor expected to open soon [6][11]. Industry Prospects - The global diabetes device market was valued at $32.74 billion in 2024 and is projected to grow at a compound annual growth rate of 7.7% through 2034 [12]. - Key factors driving market growth include rising obesity rates, increased health consciousness, and advancements in diabetes monitoring technology [13]. Recent Developments - In July, Medtronic received CE Mark approval to expand the MiniMed 780G system's indications for use in individuals aged two years and older, during pregnancy, and for type 2 insulin-requiring diabetes [14].