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    270Surgical Wins FDA Clearance for SurroundScope Laparoscopic Imaging System

    270Surgical Ltd. has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its next generation SurroundScope System. The SurroundScope is the first laparoscopic imaging...

    Wision A.I. Achieves CE-MDR Mark Approval for AI-assisted Diagnostic Software Medical Device Supporting Colonoscopy

    Wision A.I. Ltd, a startup in the field of artificial intelligence assisted diagnostics for gastrointestinal endoscopy, today announced it received the European CE Mark...

    AppliedVR raises $36M, pursues FDA clearance of first digital therapeutic

    The company is developing a digital therapeutic using VR to manage chronic lower back pain. It recently submitted an application for de novo clearance...

    HeartVista Receives FDA 510(k) Clearance to Deliver One Click MRI™ on Siemens Healthineers MRI Scanners

    - FDA 510(k) Clearance Creates Multi-Vendor, One Click MRI™ Automation Platform to Increase Real-Time MRI Imaging Access and Accuracy for Patients - New AHA and ACC Guidelines,...

    CMR Surgical Secures Regulatory Approval for Versius in Brazil

    Global surgical robotics company, CMR Surgical (CMR), has received regulatory approval for the Versius® Surgical Robotic System from the Brazilian Health Regulatory Agency, Anvisa, paving the way for...

    ReWalk lands FDA breakthrough label for home exoskeleton device to restore ankle function after stroke

    ReWalk Robotics is picking up the pace on its trek down the FDA's review pathway. The agency has granted ReWalk’s latest offering a breakthrough device...

    FDA clears XO Cross microcatheters

    Transit Scientific this week announced that it has received FDA clearance for its hydrophilic-coated XO Cross microcatheters for guidewire support, exchange and contrast media...

    Vuno’s AI-based ECG analysis software gains breakthrough designation

    South Korean artificial intelligence (AI) developer Vuno has announced that the Korean Ministry of Food and Drug Safety (KFDA) has designated the company’s AI-based...

    FDA grants breakthrough designation to Magnus’ neurostimulation technology

    In a randomised trial, the neurostimulation technology relieved severe depression in 79% of people. The US Food and Drug Administration (FDA) has granted Breakthrough Device...

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