Yahoo Finance

Practical Guide to FDA Medical Device Submissions: 510(k), PMA and Exemption Pathways (WEBINAR)

Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Practical Guide to FDA Medical Device Submissions - 510(k), PMA and Exemption Pathways (Apr 14, 2026)" training has been added to ...
Yahoo Finance

United Health Products Provides Update on FDA PMA Application Process

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

High Failure Rate for AEDs Prompts FDA Change in Regulatory Policy

The US Food and Drug Administration's (FDA) has finalized a change in policy that will soon require all Automated External Defibrillators (AEDs) to undergo a more rigorous regulatory review process ...
manilatimes

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

TORONTO, June 25, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc. ("Spectral” or the "Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, ...
MD&M East

Abiomed’s Impella 2.5 Wins PMA Approval

Impella 2.5, the main product for Danvers, MA-based Abiomed Inc., has received FDA premarket approval (PMA) for use in elective and urgent high-risk percutaneous coronary intervention (PCI) procedures ...
Nasdaq

United Health Products Provides Update on FDA PMA Application Process

MOUNT LAUREL, NJ - (NewMediaWire) - June 24, 2024 - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company's FDA Premarket Approval (PMA) application process. Following the ...