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The European Medicines Agency (EMA) has released guidance to devicemakers and notified bodies on how drug-device combination products should comply with the EU Medical Device Regulation (MDR) that came into effect on May 26. Read More
Nearly eight years after the FDA published its final rule on the unique device identification (UDI) system, it now has issued final guidance that describes the requirements for the form and content of the UDI system. Read More
GeneMatrix said the kit can detect a variety of current strains of the deadly coronavirus, including the highly contagious Delta and Delta plus variants. Read More
CoapTech, which specializes in products for minimally invasive surgery, says the ultrasound gastrostomy procedure is as safe as conventional gastrostomy methods. Read More
In a clinical trial in 234 heavy tobacco users, the number of participants who were ready to quit smoking more than tripled in the course of the study, the company said. Read More
The CE mark certification means the software no longer needs to be adapted to the specific requirements of the EU member states and other members of the European Economic Area. Read More