This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDADENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ...
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 ...
“This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA’s continued recognition of the SCD’s potential to ...
“This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA’s continued recognition of the SCD’s potential to save lives and improve ...
"This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA's continued recognition of the SCD's potential to save lives and improve patient ...
The business obtained breakthrough device designation from the US Food and Drug Administration for the gadget. AWAK Technologies CEO Suresha Venkataraya stated, "Entering the pre-pivotal trial ...
and was granted FDA Breakthrough Device Designation last year. With PSI's renowned expertise in research, product development, and musculoskeletal care, this collaboration aims to expedite the ...
The company is developing patient-specific implants for cervical spine fusion surgery and received FDA Breakthrough Device designation for cervical fusions earlier this year. The launch of aprevo ...