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New findings on the FDA’s Breakthrough Devices Program are sparking discussion about how innovative medical technologies are evaluated after approval. The conversation highlights the importance of balancing faster access with strong clinical evidence. Read more on this.

What an abandoned heart failure trial says about 'breakthrough' devices that don’t reach patients An abandoned heart-failure trial offers a rare window into devices that the FDA deems "breakthrough" but never reach patients.

The FDA has reversed course on Regenxbio’s gene therapy review for Hunter syndrome, keeping hopes alive for a potential new treatment for this rare genetic disorder.

FDA reverses course on Regenxbio’s childhood gene therapy after rejection The FDA will reconsider approving Regenxbio's experimental gene therapy for a deadly and rare childhood brain disorder it rejected just four months ago.