FDA approval allows market entry for devices from Dexcom and Intuitive Surgical.

The entities involved

• FDA →
  • Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
  • A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56
• Dexcom →

  company that develops, manufactures and distributes continuous glucose monitoring systems

  • Tandem Mobi utilizes Dexcom G7 technology for monitoring.Mon 09:18
  • Oura announces partnerships with Dexcom and Resmed for health feature integration, while noting that regulatory uncertainty affects its product scope.Wed 08:52
• Intuitive Surgical →

  American corporation

  • Medtronic is ramping up its Hugo RAS system to compete with Intuitive Surgical, while its neuroscience unit faces competitive pressure from Stryker and Globus Medical.Sun 14:58
  • Johnson & Johnson, UnitedHealth Group, and Intuitive Surgical are noted as major players in the high-volume U.S. healthcare sector.Sat 22:42

Related events

• A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Jun 7
• FDA approval enables commercial opportunity involving CBRE Group.Sep 17
• Unregulated products are bypassing official government approval processes.Aug 12
• Future sales of a product are contingent upon obtaining the necessary FDA registration and labeling, while the state simultaneously announces actions to remove regulatory barriers.Sep 21
• FDA clearance drives market expansion and coverage for NeurAxis, Inc.Jun 7