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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Abbott

Abbott CardioMEMS™ remote heart failure monitoring reader receives FDA approval

By MedTech Intelligence Staff

…contains new design features to help empower heart failure patients and their clinicians with the daily insights they need to detect and combat heart failure progression. Abbott says it will…

…contains new design features to help empower heart failure patients and their clinicians with the daily insights they need to detect and combat heart failure progression. Abbott says it will…

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BD, Becton Dickinson

BD Gets CE Mark for Revello Vascular Covered Stent

…For placement accuracy, the stent features tantalum radiopaque markers, enabling clear visualization under fluoroscopy—even in challenging anatomy. The Revello™ Stent is delivered via a tri-axial delivery system designed for controlled…

…For placement accuracy, the stent features tantalum radiopaque markers, enabling clear visualization under fluoroscopy—even in challenging anatomy. The Revello™ Stent is delivered via a tri-axial delivery system designed for controlled…

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Stryker

Stryker launches Synchfix™ EVT, expanding options for flexible syndesmotic fixation

By MedTech Intelligence Staff

…patient care and safety at the center.” Synchfix EVT features an all-in-one system that integrates suture tensioning handles within the implant instrumentation, along with a handle design for one-handed surgical…

…patient care and safety at the center.” Synchfix EVT features an all-in-one system that integrates suture tensioning handles within the implant instrumentation, along with a handle design for one-handed surgical…

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navigating regulatory strategy

Navigating the Global Regulatory Landscape: A Foundation for Medical Device Commercial Viability

By Partha Anbil

…to this legacy burden, incorporating robust security features maintainable throughout the device’s lifespan. Financial Realities of Regulatory Compliance Achieving regulatory success requires adequate capitalization. Underfunding regulatory activities is a primary…

…to this legacy burden, incorporating robust security features maintainable throughout the device’s lifespan. Financial Realities of Regulatory Compliance Achieving regulatory success requires adequate capitalization. Underfunding regulatory activities is a primary…

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Off-label and contraindicated medical device use

The Risk of Using a Device Off-Label Versus Contraindicated

By Attly Aycock

…systems incorporate design features intended to mitigate infection risk and workflow challenges, such as cordless operation and disposable components. The contrast highlights an important regulatory reality: devices within the same…

…systems incorporate design features intended to mitigate infection risk and workflow challenges, such as cordless operation and disposable components. The contrast highlights an important regulatory reality: devices within the same…

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The Hidden Complexities of Medical Needle Design

By Kelly Peterson

…success. DFM considerations include: Hidden complexities: For example, if a needle features a protective sleeve, it requires a manufacturing process that can retract the sleeve, mold the housing, then reapply…

…success. DFM considerations include: Hidden complexities: For example, if a needle features a protective sleeve, it requires a manufacturing process that can retract the sleeve, mold the housing, then reapply…

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Boston Scientific

Nalu Medical PNS System Acquired by BSCI

…back and knee, through peripheral nerve stimulation (PNS). The therapy uses mild electrical impulses to interrupt pain signals before they reach the brain. The system features a miniaturized, battery-free implantable…

…back and knee, through peripheral nerve stimulation (PNS). The therapy uses mild electrical impulses to interrupt pain signals before they reach the brain. The system features a miniaturized, battery-free implantable…

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Disruptive Innovation in MedTech

Disruptive Innovation in MedTech: Evolving Characteristics and Modern Realities

By Partha Anbil

…efficacy at launch while competing on procedure, workflow, and care-setting redesign, rather than relying solely on device features. Physicians as intermediary customers, stricter U.S./EU oversight, and payer scrutiny shift value…

…efficacy at launch while competing on procedure, workflow, and care-setting redesign, rather than relying solely on device features. Physicians as intermediary customers, stricter U.S./EU oversight, and payer scrutiny shift value…

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Kardium pulse field ablation

Globe® Pulsed Field System receives FDA approval

…platform features real-time thermal contact sensing, dense electrode coverage for precise lesion creation, and advanced visualization tools to guide ablation strategy and confirm treatment success. Impressive clinical data from the…

…platform features real-time thermal contact sensing, dense electrode coverage for precise lesion creation, and advanced visualization tools to guide ablation strategy and confirm treatment success. Impressive clinical data from the…

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