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Shifting Venue for Patent Infringement Lawsuits

Knobbe Martens attorneys Nicholas Zovko and Brandon Smith co-authored "Shifting Venue for Patent Infringement Lawsuits" for the Orange County Business Journal Intellectual Property Law Supplement. Excerpt: The U.S....more

FDA Approves Bayer’s myBETAapp™

On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™. The myBETAapp joins the growing field of medical mobile applications, which the...more

MHRA Updates Guidance on Healthcare Apps as Medical Devices

Healthcare apps are becoming a greater part of everyday life. The increasing prominence and functionality of these apps has lead to the question of when healthcare apps should be regulated as medical devices. In the United...more

EU Reaches Deal on New Medical Device Regulations

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

FDA Issues Draft Guidance for the Use of UHMWPE in Orthopedic Devices

On February 12, 2016, the FDA issued draft guidance for the use of ultrahigh molecular weight polyethylene (UHMWPE) in orthopedic devices. The draft guidance is open for public comment for the next 90 days. According to the...more

Allergan Acquires AqueSys for $300 Million

Allergan recently announced that it has completed its acquisition of AqueSys. AqueSys is a privately held company, headquartered in Orange County, California, focusing on “commercializing implantable devices that will...more

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