Gottlieb Touts Devices For Pain Control To Help Solve Opioid Crisis
Devices, or drug-delivery device, alternatives for pain control may provide at least a partial solution to the nation's opioid abuse epidemic, FDA Commissioner-nominee Scott Gottlieb said at his April 5 confirmation hearing before the Senate Health, Education, Labor, and Pensions Committee.
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Market Intel: NANS 2018: Positive Data Intensifies Spinal-Cord Stim's Big-Four Rivalry
The market for spinal cord stimulation (SCS) systems, used for treating chronic debilitating pain, is expanding relentlessly, and companies like Abbott Laboratories, Medtronic, Boston Scientific and Nevro are all vying to gain more market share with their respective technologies. At this year's annual meeting of the North American Neuromodulation Society (NANS) in Las Vegas, physicians were presented with the latest clinical evidence backing these innovations. This article looks at the overall SCS market, discusses study findings presented at NANS and the latest innovations. It also provides insights from two established pain management specialists on factors they think will drive SCS technologies forward.
US FDA: 510(k)-Exempt Class II Devices Should Withdraw Applications
In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.
21st Century Cures Implementation: Device Provision Updates
Dozens of reforms impacting the medtech sector were signed into law Dec. 13, 2016, in the 21st Century Cures Act. Here's a breakdown of where things stand in the implementation of key provisions.