medtechdive3h
FDA breakthrough device decisions rebound after recent declines
The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...
Nasdaq1mon
SIBN Stock Up After First-In-Patient Use of FDA Breakthrough Device
TNT received the FDA’s 510(k) clearance and was awarded Breakthrough Device Designation by the FDA in August 2024. Per SI-BONE, TNT, which has been designed to address the anatomic and ...
FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDADENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ...
manilatimes1mon
Inbiome Receives FDA Breakthrough Device Designation for Revolutionary Molecular Culture ID Technology, Transforming Bacterial Diagnostics
Amsterdam, The Netherlands, 26 September, 2024 - inbiome, a leading innovator in diagnostic technologies, today announced that its Molecular Culture ID has been granted Breakthrough Device Designation ...
Nasdaq23d
FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review
Acceptance of the company’s De Novo application follows FDA’s previous granting of Breakthrough Device Designation to DrugSorb-ATR, making it eligible for priority review. The Company ...
Yahoo Finance1mon
FDA grants Breakthrough Device designation to Amphix Bio's bone regeneration product
CHICAGO, Oct. 3, 2024 /PRNewswire/ -- Amphix Bio, a company developing a new class of regenerative medicine therapies, announced today it has received a Breakthrough Device designation from the U.S.
WGN Radio23d
FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review
Acceptance of the company’s De Novo application follows FDA’s previous granting of Breakthrough Device Designation to DrugSorb-ATR, making it eligible for priority review. The Company anticipates an ...