Regulatory Approvals

Median Technologies receives FDA 510(k) clearance for eyonis LCS, an AI-based detection and diagnosis device for lung cancer screening

Median Technologies, developer of eyonis, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a...

Eyas Medical Imaging wins FDA 510(k) clearance for the Ascent3T neonatal magnetic resonance imaging system

Eyas Medical Imaging received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ascent3T Neonatal Magnetic Resonance Imaging (MRI) System, a whole-body magnetic...

FDA clears RevealDX’s AI lung nodule diagnostic

RevealDX has obtained US Food and Drug Administration (FDA) clearance for RevealAI-Lung, an artificial intelligence (AI)-based software for lung nodule risk assessment. The Washington-based company’s...

Aidoc secures FDA clearance for healthcare’s first comprehensive foundation model AI

Aidoc, the pioneer and global leader of clinical AI, announced that the U.S. Food and Drug Administration (FDA) has cleared the healthcare industry’s first...

FDA clears eMurmur’s next-gen AI heart murmur detection software

eMurmur has received FDA 510(k) clearance for its next-generation heart murmur detection software, eMurmur Heart AI (2.2). The medtech company specializes in advanced digital auscultation...

Bridge to Life wins FDA De Novo for transplant liver perfusion system

Bridge to Life has received FDA De Novo clearance for its VitaSmart hypothermic oxygenated perfusion (HOPE) system for liver transplantation. According to Duluth, Georgia–based Bridge...

SonoMotion gains FDA clearance for Break Wave device to treat kidney stones

SonoMotion has received the US Food and Drug Administration (FDA) 510(k) clearance for its Break Wave non-invasive kidney stone treatment device. The system employs low-pressure...

mOm Incubators receives FDA clearance for portable incubator

mOm Incubators Limited announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s mOm Essential Incubator, a first-of-its-kind...

SurGenTec secures FDA clearance for ION-C Facet Fixation System

SurGenTec, a medical device innovation company focused on advancing treatment options for orthopedic and spine surgery, announced FDA clearance of its ION-C Facet Fixation...
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