The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Johnson & Johnson (J&J) MedTech’s Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps ...
The meetings support the company’s submission for its bioengineered corneal implants to eliminate corneal blindness.
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device ...
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...
Timur Resch, Global Vice President QM/QA/RA, added: “The PMA approval is a major milestone and reflects many years of diligent work. We thank the FDA for its collaboration in bringing this ...
Corneal blindness affects more than 13 million people worldwide and more are waiting for corneal transplants. Human donated tissue has less than 50% success rate at five years. Other challenges ...
Boston, Massachusetts-- (Newsfile Corp. - January 15, 2025) - Berman Tabacco announces that it is investigating potential securities law violations by TransMedics Group, Inc. ("TransMedics" or the ...
Scorpion Capital announced plans to file a Citizen Petition with the FDA, requesting the suspension of Premarket Approval (PMA) for TransMedics’ Organ Care System (OCS). The short seller also ...
the United States Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for RECELL GO mini. The company notes that as a line extension of the existing RECELL GO ...
Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced topline results from the AUDACITY Food & Drug Administration (FDA) pivotal trial evaluating the safety ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback