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Latest From Hoya Corp.
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.
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.
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.
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 Devices