Editor's Note The Food and Drug Administration (FDA) on July 11 announced a list of 1,003 Class II devices that the Agency says no longer require premarket notification to provide reasonable assurance of safety and effectiveness. The exemptions were made in an effort to decrease regulatory burdens on the medical…

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Editor's Note The Food and Drug Administration (FDA) on June 30 issued a draft guideline: “Product Identifier Requirements Under the Drug Supply Chain Security Act−Compliance Policy.” The draft guidance describes the FDA’s enforcement of requirements related to unique device identification (UDI), specifically those that manufacturers affix or imprint on a…

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Researchers at the University of Michigan (U-M), Ann Arbor, have invented a new surgical instrument with the goal of addressing a vast, unmet need in minimally invasive surgery. For less than a thousand dollars, this platform technology—currently being commercialized by the start-up FlexDex Surgical—offers capabilities similar to those of the…

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Editor's Note ECRI Institute on May 5 announced that Penn Medicine Center for Health Care Innovation in Philadelphia was the winner of the 11th Health Devices Achievement Award. Penn Medicine received the award for its technology platform designed for creating custom apps to help clinicians better manage specific patient populations.…

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Healthcare lags behind other industries when it comes to innovation. That’s partly because new treatments must be vetted for safety and efficacy, and partly because fee-for-service reimbursement sparked little incentive for creativity and efficiency. Under value-based purchasing, OR leaders have more opportunity to be innovative, but first they must understand…

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Editor's Note Researchers at the University of Michigan (U-M), Ann Arbor, have invented a new $500 surgical instrument that is vying to replace the $2 million deVinci robot for minimally invasive surgery. FlexDex, a mechanical platform that mounts to the surgeon’s arm, enables the tip of an instrument to mimic…

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Editor's Note ECRI Institute (Plymouth Meeting, Pennsylvania) on February 21 released a free mergers and acquisitions infographic.  The infographic is intended to help hospitals and health systems who have completed a merger or acquisition to identify supply-item savings and opportunities and develop a consolidated medical equipment strategy. Registration required.   You…

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Editor's Note A new survey shows the US implantable device market is expected to reach $73.9 billion by 2018, the January 6 Becker’s Spine Review reports. Among the survey findings: The market was valued at $43.1 billion in 2011. An increasing aging population, number of chronic degenerative diseases, and healthcare…

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Editor's Note Mount Sinai Health System (New York City) on December 6 announced its Medical Modeling Core, a collaboration led by the neurosurgery department, where clinicians can order 3D models for their cases. Virtual reality, simulation, and 3D printing services will be provided with quick turnaround times and at significant…

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Editor's Note Chicacgo-area hospitals are using apps to help patients prepare for and recover from surgery and communicate their symptoms, the November 30 Chicago Tribune reports. Amita Health is now using the TapCloud app with good results−of 309 orthopedic patients who have used the app, none have had to be…

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