In addition, the finalization of Module 3 is ongoing. The US FDA has agreed to a modular submission process for the RefluxStoptm PMA application, which allows for ongoing review and feedback from the ...

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including the unique device RefluxStop™ for the treatment of acid reflux, a treatment field ...

MaxCyte, Inc., a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics, ...

The McDonald's logo is pictured in front of a store in Dearborn ... coli outbreak in the United States, according to CDC. The ...

The research also highlights potential avenues for repurposing existing drugs. Researchers found that trimethoprim and ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs ...

Presented positive interim data for 4D-150 in wet age-related macular degeneration (wet AMD) from PRISM Phase 1/2 clinical trial highlighting ...

Abbott's Freestyle Libre 2 and 3 are the first CGMs to receive FDA clearance for use during imaging tests like X-rays, CT scans, and MRIs.

A New York federal judge on Tuesday dismissed about 100 lawsuits that claimed Procter & Gamble , Haleon and other companies ...

Senators push a bill to increase federal research on menopause, coordinate the federal government’s existing programs ...

While personally “disappointed” about the election’s outcome, current FDA Commissioner Robert Califf, M.D., has laid out the ...

NEW YORK, Nov. 13, 2024 /PRNewswire/ -- Fourth Frontier, a medical technology company based out of New York and Bangalore, announced the 510(k) clearance of the Frontier X Plus from the U.S. FDA. The ...