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    Regulatory Approvals

    Fusion Robotics™ Receives 510(k) Clearance for Spinal Navigation & Robotics System

    Fusion Robotics LLC, a spinal robotics and navigation company today announced receiving 510(k) clearance to market their 3D imaging compatible navigation and robotic targeting...

    J&J’s Covid-19 vaccine gets vote of confidence from FDA advisory panel

    The committee voted 22-0 on the question of whether the benefits of Johnson & Johnson's Covid-19 vaccine outweigh its risks. FDA emergency use authorization...

    Gala Therapeutics Receives FDA Approval to Commence Pivotal Trial to Evaluate the RheOx™ System for Chronic Bronchitis

    Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announces U.S. Food and Drug Administration (FDA) conditional Investigational Device Exemption...

    Brainlab Loop-X Mobile Imaging Robot and Cirq Robotic Alignment Module for Spine Both Receive FDA clearance

    Brainlab announced today that the company has reached two major milestones with the FDA clearance for both Loop-X® Mobile Imaging Robot and Cirq®​​, a robotic...

    AI-based voiceprint screener for COVID-19 nets European approval

    From taste and smell to muscle aches and “COVID toes,” the coronavirus affects the body in a variety of ways—including small changes in a...

    OpSens Obtains CE Marking for the OptoWire III

    OpSens Inc. ("OpSens" or the "Company") (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company commercializing a second-generation fiber optic pressure guidewire to diagnose and treat coronary...

    Infant monitoring tech brand Owlet announces SPAC merger for Q2 2021

    The company currently sells connected wearables and smart monitors to consumers but said that it will be seeking FDA authorization for new products with...

    Stroke treatment device from Israel’s BrainQ wins FDA ‘breakthrough status’

    Only about 5% of victims in the US currently arrive at the hospital in time to benefit from currently approved treatments. BrainQ's AI-based device...

    FDA greenlights Visby Medical’s single-use, portable PCR test for COVID-19

    Visby Medical received a new emergency authorization from the FDA for its rapid, single-use PCR test designed to detect COVID-19 infections at the point...
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