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Medical device FDA 510(k) approvals are still challenging (Weekend Rounds)

Life science current events this week include medical device FDA approvals, a move from University Hospitals Cleveland to Mayo Clinic for Dr. James Levine, and job advice for medical device marketers.

A review of life science current events reported by MedCity News this week:

Small medical device companies shorted by FDA 510(k) review, study says. Northwestern University researchers did an online survey of 350 medical technology professionals between December and February. They found two-thirds of small American med tech firms are getting European market approval first compared with only 4 percent who report going the domestic route first and getting FDA approval.

University Hospitals’ James Levine is again Mayo Clinic’s James Levine. “A little over six months ago Dr. James Levine was University Hospitals Case Medical Center’s prestigious new recruit – a rockstar doctor from Mayo Clinic who helped pioneer the treadmill desk and won international acclaim as a groundbreaking obesity researcher. Now, Levine has gone back to Mayo, leaving in his wake lots of unanswered questions about why his stay with Cleveland’s University Hospitals (UH) was so brief.”

bioMerieux buys microbiological analysis firm AES for $260M. “Diagnostics company bioMerieux (PARIS:BIM) is acquiring French microbiological analysis company AES Laboratoire for $260 million. France-based bioMerieux, which has its U.S. headquarters in Durham, North Carolina, gains AES’ expertise in analyzing microbiological samples in industrial settings. The acquisition is bioMerieux’s ninth in five years.”

Jobs advice: Go retool if laid off from MDT, BSX marketing departments. If you have been laid off from the marketing department of any medical device firm and believe that you will land another job in the same field, be it full time or part-time contract work, perhaps you also believed in the May 21 rapture. Get a clue and find a way to retool.

Sans Hawkins or Ishrak, Medtronic CFO fields questions on Q4 results. “Neither outgoing chairman and CEO Bill Hawkins nor his incoming replacement Omar Ishrak were present at Medtronic’s fourth-quarter earnings call Tuesday. So, CFO Gary Ellis, who typically defers questions from analysts to the CEO, took the lead instead. (Ishrak takes over June 13)”

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