News of Note—CDRH sent one warning letter to devicemakers this year

News of note

> In a sharp drop from the 18 warning letters it sent by July 2016, the FDA’s Center for Devices and Radiological Health issued a single warning letter this year—to St. Jude Medical about its implantable cardiac devices. Bloomberg story

> ExThera earned the FDA’s Expedited Access Pathway designation for its Seraph blood filter, a device designed to remove pathogens from whole blood. Release

> The FDA cleared Smiths Medical’s wireless, ambulatory infusion pump. Release


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