Results from the iDose TR exchange trial showed a second administration and removal of the original implant was safe and well tolerated over 12 months.
According to Leadoptik's FDA application, the LIA catheter is an OCT-guided biopsy needle designed for use with endobronchial ...
FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
Medical Device Network on MSN
Intuitive receives FDA clearance for non-force feedback instruments in cardiac procedures
Intuitive CEO Dave Rosa highlighted that the clearance related to “several cardiac” procedures for non-force instruments used ...
Phraxis Inc. today announced the successful initiation of its Post-Approval Study (PAS) for the EndoForce™ Anastomotic ...
Mesoblast reports early real-world data showing 84% survival in children treated with FDA-approved Ryoncil, as the company expands hospital access and prepares an adult trial.
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
In the first year of the second Trump administration, we have seen the Food and Drug Administration (FDA) take an ...
It's not a drug, and it may also have some benefits to quell overeating—here's how tech is transforming mental health care.
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results