Annalise.ai Receives FDA Clearance and Breakthrough Device Designation
First ever radiology triage device to be awarded this status under the FDA Breakthrough Devices Program
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First ever radiology triage device to be awarded this status under the FDA Breakthrough Devices Program
/PRNewswire/ -- Limaca Medical ("Limaca") announced today that its Precision GI™ Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the U....
CytoSorbents Reports Fourth Quarter and Full Year 2022 Results Pivotal U.S. and Canada STAR-T Trial enrollment passes halfway mark. Positive sales ...
The developer of the Elevate heart pump system, Magenta Medical, recently announced the completion of its FDA-approved Early Feasibility Study for the high-risk percutaneous coronary intervention (HR-PCI) indication.
Received FDA Breakthrough Device Designation for Candida auris test, achieved record quarterly sepsis test panel orders and received second largest sepsis driven T2Dx® Instrument order LEXINGTON,...