Regulatory Approvals

Accuray Incorporated (NASDAQ: ARAY) announced that has received CE Mark certification for its ClearRT™ helical fan-beam kVCT imaging capability. The Accuray-only ClearRT technology is now available...

Sofia® Q device features a miniaturized, AI-powered design Quidel plans initial release to professional and point-of-care segments with a goal of expansion to serve telemedicine and...

Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval for Vanta™, a high performance...

Device is FDA IDE approved to start a clinical study in the U.S. to investigate a novel cardiac arrest treatment indication Neurescue, a medical device...

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...

In a first for the use of artificial intelligence in healthcare, the FDA has given a green light to a program designed to help...

Avicenna.AI announces the introduction of CINA CHEST, including AI tools for detection and emergency triage of pulmonary embolism and aortic dissection Medical imaging AI specialist Avicenna.AI announced...

WB001 is the first digital therapeutic designed to reduce the burden of postpartum depression Woebot Heath, a pioneer in the development of relational technologies and tools to...

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...