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Medtronic Launches Deep Brain Stimulation Clinician Programmer for Use with Samsung Tablet
  • Knobbe Martens
  • USA
  • July 2 2018

Medtronic recently announced that the U.S. Food and Drug Administration (FDA) has approved its Deep Brain Stimulation (DBS) Clinician Programmer and


The FDA’s Medical Device Innovation Challenge: A New Approach to Combat the Opioid Epidemic
  • Knobbe Martens
  • USA
  • June 28 2018

On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The


FDA Unveils Update to Software Precertification Program
  • Knobbe Martens
  • USA
  • June 26 2018

The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in


FDA Announces Public Meeting on Regulation of Cultured Meat Products
  • Knobbe Martens
  • USA
  • June 22 2018

In recent years, market interest in meat substitutes has aligned with advances in cell culture techniques to support the emergence of lab-grown meat


Right to Try Act Gives Terminal Patients Opportunity to Try Early Therapies
  • Knobbe Martens
  • USA
  • June 19 2018

Often those with terminal illnesses wish to try new experimental therapies. Now they can if they are willing to accept the risks. On May 30, 2018


First Prosthetic Iris Approved
  • Knobbe Martens
  • USA
  • June 12 2018

On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first


FDA Announces Innovation Challenge for Devices to Prevent and Treat Opioid Use Disorder
  • Knobbe Martens
  • USA
  • June 11 2018

The Food and Drug Administration (FDA) announced a medical device innovation challenge to help address opioid abuse and misuse. The FDA Innovation


FDA Commissioner Plans to Create a Fast Track Approval Pathway for Certain Gene Therapies
  • Knobbe Martens
  • USA
  • June 7 2018

During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner


First Thrombectomy Device Cleared for Pulmonary Embolisms
  • Knobbe Martens
  • USA
  • May 30 2018

The FDA announced 510(k) clearance for Inari Medical’s FlowTriever device for the treatment of pulmonary embolism (“PE”). According to Inari, the


FDA Approval for Auris’ Robotic Endoscopy Platform
  • Knobbe Martens
  • USA
  • April 11 2018

On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris’ new system for robotic endoscopy. According to Auris Health