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FDA OKs Device for Pediatric Kidney Injury Due to Sepsis

The device was granted a Humanitarian Device Exemption approval ....

New York , United States , Eric Schlorff , Seastar Medical , Humanitarian Device Exemption , New York City ,

Nuwellis' Distribution Partner, SeaStar Medical, Receives

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people. ....

Dunia Cristan , Aquadex Smartflow , Nestor Jaramillo Jr , Eric Schlorff , Vivian Cervantes , Office Of Orphan Products Development , Seastar Medical Holding Corporation Nasdaq , Nuwellis Inc , Drug Administration , Seastar Medical Holding Corporation , Gilmartin Group , Star Medical Holding Corporation , Seastar Medical , Humanitarian Device Exemption , Selective Cytopheretic , Nestor Jaramillo , Orphan Products Development , Star Medical , Private Securities Litigation Reform Act , Selective Cytopheretic Device , Critically Ill Children , International Reports , Pivotal Study , Acute Kidney Injury , Immunomodulation Treatment , Clinical Outcomes ,

SeaStar Medical (ICU) Granted FDA Humanitarian Device Exemption Approval to Selective Cytopheretic Device

SeaStar Medical (ICU) Granted FDA Humanitarian Device Exemption Approval to Selective Cytopheretic Device
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Eric Schlorff , Nestor Jaramillo Jr , Seastar Medical Holding Corporation Nasdaq , Office Of Orphan Products Development , Drug Administration , Seastar Medical Holding Corporation , Humanitarian Device Exemption , Approval Order , Selective Cytopheretic Device , Humanitarian Use Device , Seastar Medical , Nestor Jaramillo , Nuwellis President , Orphan Products Development ,

Profound Medical To Release Fourth Quarter And Full Year 2023 Financial Results On March 7 – Conference Call To Follow

Profound Medical To Release Fourth Quarter And Full Year 2023 Financial Results On March 7 – Conference Call To Follow
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Stephen Kilmer , Health Canada , Drug Administration , China National Medical Products Administration , Full Year , Conference Call Details , Call Registration , Humanitarian Device Exemption ,

Are Higher Standards for Expedited FDA Approvals Needed?

Many clinicians have reported a lack of understanding of the FDA approval process and a desire for strong premarket evidence to support these approvals.
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Sanket Dhruva , University Of California San Francisco , Health Affairs , Health Aff Millwood , California San Francisco , Breakthrough Therapy , Innovation Act , Into Priority Review , Accelerated Approvals , Prescription Drug User Fee Act , Humanitarian Device Exemption , Premarket Notification , Premarket Approval Application , Ensure Knowledge , Drug Evaluation , Drug Trials Snapshots Summary Report , The Fda Approval Process ,