FDA Output, February 2025
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in February 2025. Updated on February 13, 2025.
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Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in February 2025. Updated on February 13, 2025.
Supported by the prolific Israeli accelerator MEDX, this start-up is improving the safety profile of endoscopic GI procedure ERCP.
Obstructive sleep apnea is the perfect market for medtech innovation: a successful first mover in Inspire Medical, a validated mechanism of action, and a significantly undertreated patient population. Emerging companies are poised to capitalize on the opportunity. Excerpted from our recent feature, Wake Up Call for Sleep Apnea Devices.