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Tuesday, September 4, 2012

OptiMedica gets FDA market clearance for laser cataract system

OptiMedica Corp. has been granted U.S. Food and Drug Administration 510(k) market clearance for its "Catalys Precision Laser System" for single-plane and multi-plane cuts in the cornea during cataract surgery, according to a release.
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Dates to Watch

Sept. 5 - PDUFA date for Salix Pharmaceuticals' crofelemer (developed by San Francisco's Napo Pharmaceuticals) for diarrhea in HIV/AIDS patients on antiretroviral therapy.
Oct. 19 - PDUFA date for Impax Pharmaceutical's IPX-066 in Parkinson's
Oct. 23 - PDUFA date for Hyperion Therapeutics' Ravicti in urea cycle disorders.

Calendar

  • "Ushering in the New Medical Device Excise Tax: Will You Be Ready?" 8 a.m. Wednesday, Sept. 5, Abbott Vascular, 3200 Lakeside Drive, Santa Clara. Cost: $20 BayBio members, $40 non-members (through Sept. 3) and $40 members and $75 non-members (after Sept. 3)
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