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 automated insulin dosing system (Medtronic’s MiniMedG) to include children as young as age 7; the world’s smallest heart valve for newborns; the world’s first blood test (Banyan Biomarkers’ Brain Trauma Indicator) to evaluate mild traumatic brain injury (concussion); technologies using artificial intelligence to detect diabetic retinopathy in adults with diabetes (IDx’s IDxDR software) and for aiding providers in the detection of wrist fractures (Imagen Technologies’ OsteoDetect). The agency also approved the first artificial iris in the U.S. (HumanOptics’ CustomFlex) and permitted marketing of a new prescription medical device that measures eye movement as an aid in the diagnosis of concussion.

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