13 December 2024
13 December 2024
The company has collaborated with ACTION to gather real-world data supporting the on-label use of heart pumps.
The framework seeks to make the UK a desirable clinical trials location by expediting approvals and raising participant diversity.
Funding for the trial is provided by the European Union Horizon Europe Programme.
FemPulse’s CEO Alexandra Haessler said the FemPulse Ring was designed as an “internal wearable” with a “set it and forget it” approach.
The FDA’s early alert communication is part of the agency’s communications pilot to enhance the medical device recall programme.
The agreement includes Cerapedics' i-FACTOR Bone Graft Putty and i-FACTOR Bone Graft FLEX FR products.
The trial expansion was granted after RevBio demonstrated the safety of Tetranite in the first five treated patients.
The findings from the study demonstrated a substantial decrease in reoperation rates when the Histolog scanner was utilised.
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