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 ...
Nasdaq22d
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 ...
Medindia23d
Teal Health Announces FDA Submission of the Teal Wand™ and Shares Report Showing 94% of Women Prefer At-Home Cervical Cancer Screening
This submission, which received FDA Breakthrough Device Designation in May of this year, is the final step before making the Teal Wand commercially available. Teal Health's SELF-CERV clinical ...
WGN Radio22d
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 ...