The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...
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 ...
Neurotechnology company Neuralink has secured a breakthrough device designation from the US Food and Drug Administration (FDA ...
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDADENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ...
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 ...
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 ...
This grant highlights the FDA’s recognition of the potential impact of inbiome’s technology in transforming the landscape of infectious disease diagnostics. The prestigious and highly competitive ...