Chembio Diagnostics, Inc. reports that it has filed the second module of its Pre-Marketing Approval (PMA) application to the United States Food & Drug Administration for its DPP® HIV 1/2 Assay which ...

Perimeter Medical Imaging AI (PYNKF) announced the submission of a Premarket Approval application to the U.S. Food and Drug Administration for the Company’s next-generation Perimeter B-Series OCT ...

In response to the FDA's September 6, 2013 not-approvable letter, Guided Therapeutics (OTCQB:GTHP +0.8%) files an amendment to its PMA application for the LuViva Advanced Cervical Scan. The company ...

"The FDA PMA submission is a major milestone – our first regulatory approval application for our AI-enabled wide-field OCT technology, as well as for a specific indication label," said Perimeter's ...

Rep. Jeff Flake (R-Ariz.) said Tuesday he will ask the Office of Congressional Ethics to disclose more than 200,000 documents from its investigation of the PMA Group, a day after the House ethics ...

MALVERN, Pa.--(BUSINESS WIRE)--Siemens Healthcare has announced that it recently submitted to the U.S. Food and Drug Administration (FDA) its premarket approval application (PMA) for the MAMMOMAT ...