Becton, Dickinson and Co. (BD) (NYSE:BDX) reported revenue of $4.23 billion for the first quarter of fiscal year 2020, ended Dec. 31, up 1.6% from the same period a year ago. Revenue grew 2.5% on a currency-neutral basis. However, an unexpected regulatory hurdle for its Alaris infusion pumps caused the Franklin Lakes, N.J.-based company to lower its 2020 revenue and earnings guidance. Despite the shadow cast by the Alaris news, BD beat Street expectations for the quarter – clocking in at $4.23 billion vs. $4.18 billion.
PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.
