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Previous treatment options adapted surgical devices developed for adults and this is the first device specifically cleared by the FDA for pediatric use, the company said.
MedAlliance announced that its Selution SLR drug-eluting balloon (DEB) has gained a conditional FDA investigational drug exemption (IDE) for the treatment of coronary de novo lesions, which typically have been treated with stents.
The FDA has closed out a warning letter sent to Dayton, Ohio-based Innovative Sterilization Technologies (IST) in 2019 for marketing a reusable sterilization container for uses the agency had not cleared, the company said.
The company seeks to replace pulse oximeters to measure oxygen levels of sepsis, trauma, and cardiac surgery patients who are “on the verge of organ failure.”
An independent committee of the UK’s National Institute for Health and Care Excellence (NICE) has proposed that England’s National Health System (NHS) use hybrid closed-loop systems for managing difficult to control blood glucose levels in type 1 diabetics.
The European Commission has extended the transition period for manufacturers to comply with the Medical Devices Regulation (MDR), citing the limited capacity of notified bodies to ensure “a successful transition to the new regulatory framework.”
The European Commission has extended the transition period for manufacturers to comply with the Medical Devices Regulation (MDR), citing the limited capacity of notified bodies to ensure “a successful transition to the new regulatory framework.”