Regulatory Approvals

Elekta Harmony linear accelerator cleared by U.S. Food and Drug Administration Elekta (EKTA-B.ST) announced todaythat its Elekta Harmony* radiation therapy system recently received U.S. FDA...

ONWARD announced the Company has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for their ARC-IM platform for blood...

LivaNova is developing the aura6000 System to treat obstructive sleep apnea. The device will be evaluated in the OSPREY RCT Trial. The study comes...

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...