SeaStar Medical (NASDAQ:ICU) said it has received an Approvable Letter from the FDA for its Selective Cytopheretic Device Pediatric, or SCD-PED, for use in children with acute kidney injury and sepsis or a septic condition requiring kidney replacement therapy.
The medical device maker said that letter means the company’s Humanitarian Device Exemption application substantially meets the FDA’s criteria for an approvable order and outlines the remaining steps needed. It added that the remaining steps include revisions to product labeling and minor modifications to the post-approval study plan.
SeaStar said it plans to work with the agency to complete the steps and hopes to begin commercialization of the product by the end of 2023 or Q1 2024.
SeaStar Medical gets Approvable Letter for SCD-PED device
