Editor's Note Food and Drug Administration (FDA) commissioner Scott Gottlieb, MD, issued a statement December 4 on the FDA’s final guidance on medical device additive manufacturing, also known as 3D printing. The FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers, including…

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With each passing year, the business of healthcare delivery grows more complex—never more so than in 2017, when a new administration began to grapple with a major overhaul of the Affordable Care Act and changes to provider payment models. Thanks to an unprecedented number of proposals submitted for the 2018…

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Editor's Note RTI Surgical (Alachua, Florida) on October 25 launched its Fortilink-C interbody fusion system with Tetrafuse 3D technology, the October 26 Becker’s Spine Review reports. Tetrafuse 3D technology combines titanium, allograft bone, and PEEK all in one device. The 3D-printed, polymer-based, cervical interbody device incorporates micro, macro, and nano-rough…

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Editor's Note A new app developed by students at the University of Wisconsin-Milwaukee’s (UWM’s) App Brewery and a neuropsychologist at the Medical College of Wisconsin (MCW) monitors critical brain functions during neurosurgical procedures in which patients are awake. The app, called “NeruoMapper,” assists neurosurgeons who are removing tumors by helping…

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Editor's Note The Philadelphia Pediatric Medical Device Consortium (PPMDC) has chosen two companies out of eight finalists to receive grants of $50,000 each to develop medical devices for children. The devices include a: speech generating system that allows hospitalized children who are unable to speak to communicate with clinicians handheld…

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Editor's Note In this pilot trial, surgeons used a pair of magnets (ie, Harrison rings) to create an intestinal anastomosis without sutures or staples in five patients. For each procedure, one Harrison ring was placed in the lumen of each intestinal segment, and then the rings were brought together and…

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Editor's Note Researchers from Zurich, Switzerland, have created an artificial heart out of silicone using 3D printing. The artificial heart, which mimics the human heart in shape and function, presently has a lifespan of approximately 3,000 beats, or about 30 to 45 minutes. The researchers hope to develop a more…

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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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