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Results: 1-10 of 176

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


FDA Issues Refusal-to-File Letter to Alkermes for Depression Treatment
  • Knobbe Martens
  • USA
  • April 9 2018

On April 2, 2018, Irish biotech Alkermes revealed that it had received a Refusal-to-File letter from the FDA regarding its depression drug ALKS 5461


FDA grants De Novo Market Clearance of Artificial Intelligence Software
  • Knobbe Martens
  • USA
  • April 5 2018

According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO


23andMe Wins FDA Approval for Test to Detect BRCA Mutations
  • Knobbe Martens
  • USA
  • April 4 2018

The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for


23andMe Receives First FDA Authorization for Direct-to-Consumer Cancer Risk Genetic Test
  • Knobbe Martens
  • USA
  • March 23 2018

On March 6, 2018, 23andMe, Inc. received the first-ever FDA authorization for a direct-to-consumer genetic test that analyzes gene mutations to help


FDA Approves Blood Test for Concussion
  • Knobbe Martens
  • USA
  • March 16 2018

The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo


Janssen’s Erleada Will be the First Participant in FDA’s Clinical Data Summary Pilot Program
  • Knobbe Martens
  • USA
  • March 5 2018

On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen


Xeris’ Pharmaceuticals Glucagon Progresses Towards FDA Approval
  • Knobbe Martens
  • USA
  • February 28 2018

Xeris Pharmaceuticals, Inc. (“Xeris”) recently announced successful completion of both adult and pediatric clinical studies for its glucagon rescue


U.S. to Have its Own Supply of the Most Commonly Used Medical Imaging Isotope for the First Time in 30 Years
  • Knobbe Martens
  • USA
  • February 27 2018

Medical imaging isotopes are used to diagnose various diseases, such as cancer and coronary artery disease, and to evaluate brain, lung, kidney, and


FDA Clears New Surgery Infection Control System
  • Knobbe Martens
  • USA
  • February 26 2018

The FDA recently cleared Prescient Surgical’s CleanCisionTM Wound Retraction and Protection System (CleanCisionTM), a retractable device designed to