Ibex Granted FDA Breakthrough Device Designation
Ibex Medical Analytics, a specialist in AI-powered cancer diagnostics, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), which...
Cognoa’s AI app for diagnosing childhood autism gets FDA green light
In a first for the use of artificial intelligence in healthcare, the FDA has given a green light to a program designed to help...
AI triage solution for deadly vascular conditions receives FDA clearance and CE Mark
Avicenna.AI announces the introduction of CINA CHEST, including AI tools for detection and emergency triage of pulmonary embolism and aortic dissectionMedical imaging AI specialist Avicenna.AI announced...
Mental Healthtech Woebot Gets FDA Breakthrough Device Designation
WB001 is the first digital therapeutic designed to reduce the burden of postpartum depressionWoebot Heath, a pioneer in the development of relational technologies and tools to...
iRhythm gains two FDA approvals for updates to its Zio system
iRhythm Technologies has announced two US Food and Drug Administration (FDA) 510K clearances—one for a new and improved design of its flagship monitor and...
Ibex AI-enabled breast cancer diagnostic lands CE mark
Ibex Medical Analytics announced today that it received CE mark approval for its Galen AI-based breast cancer diagnostic platform.Tel Aviv, Israel–based Ibex’s Galen platform uses...
Boston Scientific Completes CE Mark for EXALT Model B Single-Use Bronchoscope
Boston Scientific Corporation (NYSE: BSX) announced it has completed CE Mark for the EXALT™ Model B Single-Use Bronchoscope, a single-use device designed for bedside...
JenaValve Technology Receives CE Mark for its Trilogy™ TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis
JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve implantation (TAVI) systems (also referred to as TAVR, or transcatheter aortic valve replacement)...
EndoFresh Obtains FDA 510(k) Clearance for Its Groundbreaking Disposable Digestive Endoscopy System
The FDA has greenlighted EndoFresh Disposable Digestive Endoscopy System, following years of reports of persistent cross-contamination issues being transmitted among multi-patients by the notoriously...