Levee Medical Completes Oversubscribed $12M+ Financing to Support PMA as ARID II Trial Progresses

Levee Medical, a medical device innovator focused on improving outcomes for men undergoing prostate cancer surgery, today announced the close of an additional round of financing totaling over $12 ...
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 ...
TCTMD

Cardiovascular Devices Make Up Largest Class of FDA Device Recalls Since 2005

While the overall percentage of medical devices approved and recalled by the US Food and Drug Administration (FDA) is relatively low, the recent increase in recalls for devices approved via the 510(k) ...
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 ...