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    Regulatory Approvals

    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...

    iotaMotion gains paediatric FDA indication for cochlear implant robot

    Robotics company iotaMotion has received a paediatric indication expansion for its robotic-assisted iotaSOFT cochlear implant insertion system from the US Food and Drug Administration...

    Amplifi Vascular wins FDA breakthrough nod for vein dilation system

    Amplifi Vascular announced that it received breakthrough device designation for its Amplifi Vein Dilation System. The St. Louis-based company also picked up Category B assignment...
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