3D printing

Medical 3-D Printing Making Rapid Strides in Asia

By Ames Gross

…lens and frames that fit customers’ unique facial features. That same month, Materialise Japan announced the opening of a new medical 3-D printing production facility in Kanagawa to provide surgical…

…lens and frames that fit customers’ unique facial features. That same month, Materialise Japan announced the opening of a new medical 3-D printing production facility in Kanagawa to provide surgical…

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gavel

Medical Device Software & Products Liability: Interoperability (Part III)

By Sara E. Dyson, Esq.

…is imperative for manufacturers to use design and labeling features to manage the risk and not simply fall back on standards to guide the product-development process. Prevent the Risk of…

…is imperative for manufacturers to use design and labeling features to manage the risk and not simply fall back on standards to guide the product-development process. Prevent the Risk of…

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Sara Dyson, Medmarc

Medical Device Software & Products Liability: The Homefront (Part II)

By Sara E. Dyson, Esq.

…marketplace ─ and the performance of “peer” products can be relevant in products liability. If a competitor product boasts design enhancements or safety features that the product in litigation omits,…

…marketplace ─ and the performance of “peer” products can be relevant in products liability. If a competitor product boasts design enhancements or safety features that the product in litigation omits,…

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gavel

Medical Device Software & Products Liability: An Overview (Part I)

By Sara E. Dyson, Esq.

…hardware safety features that would have prevented overdosing when software controls failed. Nancy Leveson, a software safety expert who researched the Therac-25 extensively for her 1995 book, Software: System Safety…

…hardware safety features that would have prevented overdosing when software controls failed. Nancy Leveson, a software safety expert who researched the Therac-25 extensively for her 1995 book, Software: System Safety…

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Mike Kijewski, MedCrypt

The Medical Devices Most Vulnerable to Hackers

By Mike Kijewski

…of internet-enabling medical devices are huge. Many patients are alive because of these tools. Device vendors, however, must begin including features that make devices harder to hack. Unfortunately, this costs…

…of internet-enabling medical devices are huge. Many patients are alive because of these tools. Device vendors, however, must begin including features that make devices harder to hack. Unfortunately, this costs…

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Medtronic Avalus aortic valve

Double Win: Medtronic Receives FDA Approval and CE Mark for Aortic Valve

By MedTech Intelligence Staff

…valve currently on the market that is MRI-safe. Intended to treat aortic valve disease, the device features a supra-annular design to limit central regurgitation and has an interior-mounted leaflet and…

…valve currently on the market that is MRI-safe. Intended to treat aortic valve disease, the device features a supra-annular design to limit central regurgitation and has an interior-mounted leaflet and…

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Checkbox

IQ, OQ and PQ: The Backbone of Your Quality System

By Edward Simpson

…various features of equipment listed below that contribute towards final quality of the product: Signaling LEDs and display units Temperature fluctuations and controls Low-temperature and overheating protection systems and alarms…

…various features of equipment listed below that contribute towards final quality of the product: Signaling LEDs and display units Temperature fluctuations and controls Low-temperature and overheating protection systems and alarms…

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3M adhesive

Ouch! Adhesives Should Protect, Not Hurt, the Skin

By Maria Fontanazza

…characteristics required, before consulting with their partner. When developing adhesives for the skin, early involvement of the material partner is critical. The skin has many features that affect how a…

…characteristics required, before consulting with their partner. When developing adhesives for the skin, early involvement of the material partner is critical. The skin has many features that affect how a…

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INSPIRIS valve, Edwards Lifesciences

Edwards Lifesciences Receives FDA Approval for Its New Class of Heart Valves

By MedTech Intelligence Staff

…clinical use behind it. The valve features tissue technology that combines anti-calcification properties, sustained hemodynamic performance and dry storage. Its VFit technology has an expandable frame and includes fluroscopically visible…

…clinical use behind it. The valve features tissue technology that combines anti-calcification properties, sustained hemodynamic performance and dry storage. Its VFit technology has an expandable frame and includes fluroscopically visible…

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