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FDA Announces Plans for Alternative Clearance Pathway
  • Knobbe Martens
  • USA
  • January 22 2018

The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance


Medtronic Pain Management Device Approved by FDA
  • Knobbe Martens
  • USA
  • January 22 2018

Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable pain. According


FDA Pre-cert Program for Lab-Developed Tests
  • Knobbe Martens
  • USA
  • January 22 2018

The FDA may begin certifying the laboratories that produce lab-developed tests ("LDTs") instead of drafting regulatory rules to cover the tests


First-Ever De Novo Clearance by FDA’s Orthopedic Branch
  • Knobbe Martens
  • USA
  • January 21 2018

According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s


FDA Clears First Apple Watch Medical Device Accessory
  • Knobbe Martens
  • USA
  • December 11 2017

The FDA recently cleared the first medical device accessory for the Apple Watch AliveCor’s KardiaBand. According to AliveCor, the Kardiaband is a


Private: FDA Takes New Steps to Advance Medical Device Innovation
  • Knobbe Martens
  • USA
  • December 11 2017

On October 24, 2017, the FDA announced new steps that it is taking to promote beneficial medical device innovation. First, the FDA completed a first


Diabetes Monitoring Technology Moving Toward Consumer Convenience
  • Knobbe Martens
  • USA
  • December 11 2017

The FDA recently approved Abott's FreeStyle Libre Flash Glucose Monitoring System. According to Bloomberg, this device marks the first continuous


FDA Provides Guidance on 3D-Printed Medical Device Products
  • Knobbe Martens
  • USA
  • December 8 2017

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on


FDA Approves Zelboraf for Treatment of a Rare Cancer
  • Knobbe Martens
  • USA
  • November 17 2017

On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester


Bayer Receives Accelerated Approval for Aliqopa
  • Knobbe Martens
  • USA
  • October 10 2017

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc