Supply Chain/Technology
Two firms awarded grants to develop medical devices for children
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…
Surgeons perform first magnetic compression anastomosis (magnamosis) in humans
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…
Scientists create artificial heart with 3D printing
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…
FDA updates Class II medical devices exempt from premarket notification
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…
FDA issues draft guideline on UDI requirements
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 The draft guidance describes the FDA’s enforcement of requirements related to unique device identification (UDI), specifically those that manufacturers affix or imprint on a…
New instrument shows promise as low-cost alternative to robot
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…
ECRI Institute: Penn Medicine wins Health Devices Achievement Award
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.…
Innovation: The path to superior OR teamwork and results
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…
U-M researchers invent low-cost robot
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…
ECRI Institute releases free mergers and acquisitions infographic
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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