FDA approves Artivion’s AMDS device PMA

Artivion has received premarket approval application (PMA) clearance from the US Food and Drug Administration (FDA) for the ...

Envoy Medical Submits First Module of Modular Premarket Approval Application to the U.S. Food and Drug Administration for Breakthrough-Designated Device

Modular Regulatory Strategy Creates Defined Milestone Cadence, Enables Earlier FDA Engagement, and Supports Targeted Final ...

Spectral Medical Announces U.S. FDA Filing of PMA Application for PMX

Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that the U.S. Food and Drug ...
Seeking Alpha

United Health Products Provides Update on FDA PMA Application Process

Mesquite, NV, March 29, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products, Inc. (UEEC) today provided an update on the company’s FDA Premarket Approval application process. As ...
Seeking Alpha

United Health Products Reiterates Guidance on FDA PMA Application Process

MESQUITE, NV, June 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products, Inc. (UEEC) today provided an update on the company’s FDA Premarket Approval application process. As ...
Medical Device and Diagnostic Industry (MD+DI)

Mastering FDA Device Approvals in Challenging Times

Basics and Beyond - Keeping Up with FDA Medical Device Submission Programs and Pilots” session MEDevice Boston 2026 on August ...

Spectral Medical Announces PMA Submission to U.S. FDA for PMX

Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced the submission of its ...