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Today's Issue of Medical Device Daily

Monday, April 27, 2015

Today's Headlines

Data supports addition of Solitaire to pharma treatment of stroke victims

Two global trials published online in the New England Journal of Medicine (NEJM) found that the addition of Medtronic's (Dublin) Solitaire stent thrombectomy procedure to current pharmaceutical treatment significantly reduced disability in patients suffering stroke. These trials confirmed the findings of three previous trials also published in NEJM, the company noted. Medtronic inherited the Solitaire device through its $42.9 billion Covidien acquisition.

Warning! The 15-day rule for FDA 483s

Device makers are by now quite aware that FDA-inspected firms have 15 working days to respond to an inspectional form 483, but is this always consistently applied? It would appear not. Whether that difference makes a difference in the issuance of warning letters is tough to know, but one might think there are reasons for misgivings. (MDD Perspectives)

Google faces potential challenges, roadblocks in getting Glass adopted

When Jay Zuerndorfer, a student researcher at the Georgia Institute of Technology (Atlanta) received the opportunity to develop an application for Google Glass it was like a dream come true. Zuerndorfer and a research team from Georgia Tech were able to create speech-to-text software for Google Glass that helps hard-of-hearing users with everyday conversations. A hard-of-hearing person wears Glass while a second person speaks directly into a smart phone.

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