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FDA Expands AI Capabilities: Launches ELSA and Completes HALO Data Platform Consolidation

By MedTech Intelligence Staff

…an urgent priority that will allow us to rapidly advance regulatory science and deliver more cures and meaningful treatments to patients faster.” New Elsa 4.0 features include: Custom agents Document…

…an urgent priority that will allow us to rapidly advance regulatory science and deliver more cures and meaningful treatments to patients faster.” New Elsa 4.0 features include: Custom agents Document…

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Data protection, intelliectual property, medtech

The Medical Device Cybersecurity Gap Hiding in Plain Sight

By Partha Anbil, Saravanan Manikandan

…buyers whether a device supports features such as patching, logging, encryption, authentication, hardening, and remote access controls. On its own, that information is useful but incomplete. The analysis of this…

…buyers whether a device supports features such as patching, logging, encryption, authentication, hardening, and remote access controls. On its own, that information is useful but incomplete. The analysis of this…

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Medtronic

Medtronic’s Updated Mitral Valve, Mosaic Neo, Gets FDA approval

By MedTech Intelligence Staff

…of mitral valve replacement surgery.” With new features such as a low-profile valve holder and first-to-market small incision sizers, this next-generation device features innovative, surgeon-inspired enhancements specifically designed to improve…

…of mitral valve replacement surgery.” With new features such as a low-profile valve holder and first-to-market small incision sizers, this next-generation device features innovative, surgeon-inspired enhancements specifically designed to improve…

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Johnson & Johnson Enters Agreement to Acquire Atraverse Medical

By MedTech Intelligence Staff

…multiple innovative features—including impedance-sensing automatic energy shutoff, compatibility with multiple sheaths, and clear tip visibility under intracardiac echocardiography—that support smooth and efficient access to the left atrium. The planned acquisition…

…multiple innovative features—including impedance-sensing automatic energy shutoff, compatibility with multiple sheaths, and clear tip visibility under intracardiac echocardiography—that support smooth and efficient access to the left atrium. The planned acquisition…

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Medtronic

Medtronic Gains CE Mark for Stealth AXiS surgical system

…surgery – before, during, and after the procedure. In cranial applications, it features AI-powered automatic tractography, allowing surgeons to create patient-specific brain maps and clearly visualize critical neural pathways linked…

…surgery – before, during, and after the procedure. In cranial applications, it features AI-powered automatic tractography, allowing surgeons to create patient-specific brain maps and clearly visualize critical neural pathways linked…

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The Healthccare Burnout Backlask (pt 4): Why Contract Negotiation Has Become a Core Strategic Skill for Healthcare Administrators

By Melissa Corneal

…evolving healthcare environment. This evolution also reflects a broader shift in how healthcare organizations define value, moving beyond a focus on cost and system features to consider the total impact…

…evolving healthcare environment. This evolution also reflects a broader shift in how healthcare organizations define value, moving beyond a focus on cost and system features to consider the total impact…

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BD, Becton Dickinson

BD Announced Application of CE Mark for the Liverty TIPS Stent Graft

By MedTech Intelligence Staff

…Graft is engineered to support individualized patient management, offering a 6–10 mm adjustable inner diameter and the broadest range of covered TIPS stent lengths currently available. Key features include a…

…Graft is engineered to support individualized patient management, offering a 6–10 mm adjustable inner diameter and the broadest range of covered TIPS stent lengths currently available. Key features include a…

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InVera Medical Receives FDA Clearance for Non-Thermal Chronic Venous Disease Device

By MedTech Intelligence Staff

…to help reduce the gap in treatment with its alternative to thermal burning technologies and current non-thermal methods. The InVera Infusion Device features a 5Fr catheter with a novel helical…

…to help reduce the gap in treatment with its alternative to thermal burning technologies and current non-thermal methods. The InVera Infusion Device features a 5Fr catheter with a novel helical…

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JenaValve

JenaValve Gets FDA Nod for Trilogy Transcatheter Heart Valve (THV) to Treat Aortic Regurgitation (ssAR)

By MedTech Intelligence Staff

…Trilogy System features three proprietary radiopaque locators that attach directly to the native aortic leaflets, enabling secure and stable implantation even in the absence of calcium. The locators also provide…

…Trilogy System features three proprietary radiopaque locators that attach directly to the native aortic leaflets, enabling secure and stable implantation even in the absence of calcium. The locators also provide…

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Philips

Philips unveils Rembra CT for acute and high-demand imaging environments

By MedTech Intelligence Staff

…overall image quality and diagnostic confidence. Integrated AI-enabled smart workflows can help automate routine steps and simplify certain operations. These features are intended to support workflow efficiency for consistent results….

…overall image quality and diagnostic confidence. Integrated AI-enabled smart workflows can help automate routine steps and simplify certain operations. These features are intended to support workflow efficiency for consistent results….

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