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How Did Artrya Secure FDA’s Green Light for Salix Coronary Flow?

10:11am on Friday 10th of October, 2025 AEDT Healthcare
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How Did Artrya Secure FDA’s Green Light for Salix Coronary Flow?

10:11am on Friday 10th of October, 2025 AEDT
Key Points
  • FDA confirms 510(k) as regulatory route for Salix Coronary Flow
  • Q-Submission meeting provides detailed FDA feedback
  • Artrya to update study design and application accordingly
  • Final 510(k) submission targeted by end of 2025
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