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Amsterdam Molecular Therapeutics

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Latest From Amsterdam Molecular Therapeutics

M&A Analysis: August Activity Cools As The Summer Closes

Medtech M&A activity slowed in the last month of summer with just 16 mergers and acquisitions recorded on the Medtech Insight M&A Deal Tracker. However, the month included one billion-dollar deal and several deals in the ophthalmological sector.

M & A Deals

Compilation: 2015 Medical Device Warning Letters

Complete list of all 91 FDA device-related warning letters released by the agency last year. The upshot: 73 domestic and 18 foreign manufacturers were sent letters.

Medical Device Regulation

Scope Firms, FDA Faulted In 300-Page Senate Report Seeking Device Reforms

Senate HELP Ranking Member Sen. Patty Murray in a staff report criticizes FDA and manufacturers for reacting slowly to duodenoscope contamination incidents in 2013. The report says FDA needs a more robust device surveillance system and calls for more attention to 510(k) modification policies. Murray is a key partner in ongoing Senate work to produce a so-called "medical innovation" bill.

Medical Device Legislation

Duodenoscope-Makers Ordered By FDA To Conduct Sec. 522 Postmarket Surveillance Studies

FDA orders three duodenoscope manufacturers – Olympus America, Fujifilm Medical Systems and Hoya Corp.'s Pentax Life Care Division – to conduct postmarket surveillance studies to better understand how the scopes are being reprocessed and how to reduce the risk of patient infection. The firms told "The Gray Sheet" that they will comply with the agency's request.

Medical Device Quality
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