The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
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The 17 most innovative medical devices of 2019
The Galien Foundation recently announced nominees for most innovative medical devices for its 13th Annual Prix Galien USA Awards. The foundation awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Nominees need to be FDA approved for market within the last five […]
FDA sets approval record, lays out 2019 strategy
FDA said today that it set a record for novel-device approvals in 2018, giving the nod to 106 new devices, breaking the previous record of 99. The agency also granted nine breakthrough device designation requests, for a total of 112 since the program’s inception in 2015. Novel-device approvals in 2018 included an expanded approval of an […]
FDA clears first artificial iris from HumanOptics
The FDA today granted pre-market approval and a breakthrough device designation for HumanOptics‘ CustomFlex artificial iris, touting it as the first stand-alone prosthetic iris to win approval in the US. The CustomFlex artificial iris is designed to be surgically implanted in adults and children to treat individuals whose iris is completely missing or damaged due […]