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Corindus Vascular Robotics received 510(k) clearance for the first automated robotic software designed for its CorPath GRX surgical platform. Read More
Instruments were measured by their ability to predict disability and mortality, validation status, feasibility of use across therapeutic areas, time required, training requirements and cost. Read More
Next year, the FDA will begin to require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent. Read More
The FDA hit Pacific Hospital Supply, a manufacturer of disposable medical supplies including catheters, cannulae, tubing, and aspirators, with a warning letter after an inspection at the firm’s Miaoli, Taiwan facility revealed adulterated products. Read More