Regulatory & Reimbursement
FDA Output April 2024
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in April 2024. Updated April 30, 2024.
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Executive Interviews
Stephen Kingsmore’s Quest for Rapid, Universal Whole Genome Sequencing of Newborns
As advances in gene and cell therapies make the possibility of curing some inherited genetic diseases a reality, the need for rapid screening and diagnosis of genetic variants is getting more urgent. Immunologist and cell therapy expert Stephen Kingsmore is at the forefront of making that happen.
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Regulatory & Reimbursement
Pathways' Pick of the Week: EU Scientific Advice Pilot Expanded
The EU adds an extra round to its ongoing “scientific advice” pilot for high-risk devices. Excerpted from Pathways’ Picks April 2: EU Advice Pilot Extends, NTAP Watch, FDA Standards Scheme Starts Small.