Editor's Note A Market Research Future report predicts the global market for spinal implants will reach $14 billion by 2011 because of an increasing prevalence of spinal injuries and disorders and an aging population, according to the July 5 Becker’s Spine Review. The costliness of spinal implants and unfavorable reimbursement…

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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 The draft guidance describes the FDA’s enforcement of requirements related to unique device identification (UDI), specifically those that manufacturers affix or imprint on a…

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Editor's Note This Australian study finds it is a good economic decision for large healthcare facilities to invest in low-temperature systems for sterilization of steam-sterilizable endoscopes. Increased costs associated with low-temperature systems were outweighed by savings from fewer instrument repairs. Based on their calculations, the researchers estimated a savings of…

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Editor's Note The Food and Drug Administration (FDA) has announced the creation of a new centralized Digital Health Unit in its Center for Devices and Radiological Health, which together with draft guidance on software as a medical device, is designed to support technological innovation and advance digital health, the June…

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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 The Food and Drug Administration (FDA) on June 15 issued a Safety Alert for frameless stereotaxic navigation systems because of navigational accuracy errors during surgical procedures. Some of these errors have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged surgical procedures. The FDA…

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Editor's Note The global market for gastrointestinal (GI) endoscopy devices is expected to see a compound annual growth rate of 5.09% through 2020, the June 13 Becker’s GI & Endoscopy reports. A large, growing patient pool is driving growth, but risks and complications tied to GI endoscopy procedures also will…

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Editor's Note The Food and Drug Administration (FDA) on June 9 released a list of reusable devices that will require new validated instructions for use (IFU) and validation data in premarket notifications regarding cleaning, disinfection, and sterilization. These actions are effective August 8, 2017. The list includes: Bronchoscopes (flexible or…

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Editor's Note The Food and Drug Administration (FDA) has notified medical device labelers that the compliance dates for unique device identifier (UDI) requirements for Class I and unclassified medical devices has been extended from September 24, 2018, to September 24, 2020, and for direct mark requirements from September 24, 2020,…

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Editor's Note ECRI Institute on June 6 announced the release of CrossCHEQ, its new service that offers unbiased guidance on equivalent alternatives for medical-surgical supplies and implants. By comparing key performance indicators, buyers can assess opportunities for standardization and better respond when products are out of stock or recalled. The…

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