FDA Announces “Record Year For Device Innovation”

The FDA announced a record year of novel device approvals and clearances in 2018, with 106 applications authorized for marketing. (“Novel” applications as defined by the FDA encompass original PMAs, panel track supplement PMAs and de novos; for 2019, that definition was broadened to include HDEs and breakthrough 510[k]s.) The 2018 approval rate broke the previous record of 98 applications approved or cleared set in 2017, which itself broke a 40-year record. The agency highlighted several of their novel device authorizations, including the 510(k) de novo clearance of Imagen Technologies’ OsteoDetect, an AI-based diagnostic for the detection of wrist fractures, and Banyan Biomarker’s blood-based diagnostic for traumatic brain injuries, which was approved under the Breakthrough Device program. A total of nine breakthrough devices were approved or cleared in 2018.

The announcement comes as the FDA is in the process of modernizing its 510(k) pathway. Innovative device approvals are already off to a strong start in 2019. This week alone, Medtronic received approval on an expanded indication for its Pipeline Flex embolization device for use in aneurysms; Teleflex received approval for its Manta vascular closure device; and Orthofix received approval for the M6-C artificial cervical disc.