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 24, 2024.
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Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in April 2024. Updated April 24, 2024.
Proper monitoring during hemodialysis is crucial for catching complications early before they develop into more costly and health-threatening situations, yet most clinicians lack the time to implement it consistently. PatenSee’s contact-free solution aims to improve monitoring protocols without adding to the clinical workload.
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.