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  • FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways

    The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an "abbreviated" and a "special" approach to the typical 510(K) process for medical devices. The FDA describes the usual 510(K) process as "a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, ...
  • PTAB Institutes Inter Partes Review of Medtronic “Jervis” Patent

    On June 11, 2019, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) instituted inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc.  The Decision instituted the IPR based on two obviousness grounds, including that "Petitioner has made an adequate showing at this stage that at least claim 1 would have been obvious over Cragg, Pops, a ...
  • New Motion Sickness Glasses Launched

    In July 2018, Citroën, the French car manufacturer, unveiled glasses that aid in alleviating motion sickness.  The “Seetoën” glasses, developed by Boarding Ring, purports to eliminate motion sickness symptoms within about 10 minutes of putting them on.  According to Boarding Ring, the Boarding Ring technology includes four rings filled with blue liquid. With the increase of use of ...
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