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A group of researchers representing devicemakers, academic institutions and the FDA has published a list of factors device developers should consider when collecting patient preference information (PPI) to help design trials. Read More
A Rhode Island state jury has awarded $4.8 million in damages against Becton Dickinson for alleged injuries caused by its Ventralex surgical hernia repair mesh product. Read More
Philips Respironics is voluntarily recalling certain sleep therapy masks due to concerns that their magnetic headgear clips or straps could adversely impact metallic implanted devices or other metallic objects inside the body. Read More
One year into implementation, the EU Medical device regulation (MDR) is undergoing some growing pains. A number of new developments have arisen to challenge devicemakers learning how to comply with the new regulation. These developments include introductions of new guidances, new harmonized standards and common specifications, plus different interpretations offered by the Medical Device Coordinating Group (MDCG). Read More
Excellus Holdings, San Diego, Calif., has drawn an FDA Form 483 for inspectional observations that include senior management passing the buck on customer complaints. Read More
Medcura’s injectable biopolymer LifeFoam significantly extended survival time in an animal study, researchers reported in the journal Surgery. Read More
Philips has agreed to pay more than $24 million to resolve False Claims Act allegations that it misled federal health care programs by paying kickbacks to durable medical equipment (DME) suppliers, said the Department of Justice (DOJ) in a statement. Read More
The EU Medical Devices Regulation (MDR) went into force May 26, 2021. Since then, a flurry of new standards, guidances and other regulatory instruments have come out to help explain or support the MDR, with many more yet to come before the regulation’s transition period ends in May 2024. Read More