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FDA Grants SeaStar Medical Two New Breakthrough Device Designations for SCD Therapy to Treat Systemic Inflammatory Response in Adult and Pediatric Patients Undergoing Cardiac ...

DENVER, April 08, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients ...
Seeking Alpha

FDA Grants Breakthrough Device Designation to SeaStar Medical’s Selective Cytopheretic Device for Cardiorenal Syndrome

DENVER, Sept. 29, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation ...
Cure Today

FDA Grants Breakthrough Device Status to MRD Test in Colorectal Cancer

Haystack MRD test detects minimal residual disease in stage 2 colorectal cancer patients post-surgery, using circulating tumor DNA (ctDNA) for less invasive monitoring. The FDA's breakthrough device ...
The Business Journals

Bham professor secures $2.4M for medical device studies

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min Two awards are for $1.2 million ...
Becker's Hospital Review

FCC grants GE Healthcare waiver to expedite medical devices

The Federal Communications Commission has accepted GE Healthcare’s request for a waiver, allowing for faster importation and marketing of medical equipment from new suppliers. The waiver, accepted May ...