SeaStar Medical Provides Regulatory Update Regarding Selective Cytopheretic Device Use In Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption; Announces FDA Receipt
Portfolio Pulse from Benzinga Newsdesk
SeaStar Medical has announced that it has received a Humanitarian Device Exemption from the FDA for the use of its Selective Cytopheretic Device in pediatric acute kidney injury. The news was disclosed in a recent SEC 8K filing.
October 03, 2023 | 8:14 pm
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SeaStar Medical's FDA approval for its Selective Cytopheretic Device could potentially increase demand for ICU's products and services.
The FDA approval for SeaStar Medical's device indicates a positive regulatory environment for medical devices. This could potentially increase demand for similar products and services offered by ICU. However, the direct impact on ICU is not explicitly mentioned in the article.
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