FDA Grants SeaStar Medical's Selective Cytopheretic Device Breakthrough Device Designation For Hepatorenal Syndrome
Portfolio Pulse from Benzinga Newsdesk
SeaStar Medical Holding Corporation (NASDAQ:ICU) has received the U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its Selective Cytopheretic Device (SCD) for use with patients with acute kidney injury and acute on chronic liver failure. This is the third such designation granted to SeaStar for the SCD device, which is expected to expedite its clinical development and regulatory review. The SCD has shown potential in improving solid organ function in various conditions, including sepsis, AKI, cardiorenal syndrome, and COVID-19.
October 18, 2023 | 12:33 pm
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SeaStar Medical's receipt of the third FDA Breakthrough Device Designation for its SCD device is expected to expedite its clinical development and regulatory review. This could potentially lead to increased investor interest and a positive impact on the company's stock.
The FDA Breakthrough Device Designation is granted to devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. This designation for SeaStar's SCD device could expedite its development and review, potentially leading to earlier market entry and increased revenues. This could attract investor interest and positively impact the company's stock in the short term.
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