Medical Device Network

FDA grants 510(k) clearance to TaeWoong Medical for Spaxus EUS stent

TaeWoong Medical has secured the US FDA clearance to commercialise the Niti-S Spaxus Stent, expanding its range of EUS-guided therapeutic solutions.
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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 ...
Labroots

FDA Grants "Breakthrough Device Designation" for Early Cancer Detection Test

The United States Food and Drug Administration (FDA) issued guidance on its “Breakthrough Devices Program” in 2023. The program grants a designation to certain medical devices that provide more ...
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FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis

DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of ...
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 ...
Nasdaq

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

DENVER, Oct. 18, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation ...
Healio

FDA grants 510(k) clearance to Limaca Medical for endoscopic ultrasound biopsy device

Please provide your email address to receive an email when new articles are posted on . The FDA granted 510(k) clearance to Limaca Medical’s Precision GI endoscopic ultrasound biopsy device, following ...