Olympus has updated use instructions after reports that the ligation loop may not release as expected, potentially requiring emergency intervention. The US Food and Drug Administration (FDA) issued a medical device recall early...
The FDA issued a safety alert after users reported nitric oxide dose fluctuations, potentially leading to hypoxemia or increased pulmonary artery pressure.
The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.
The vendor-agnostic system enables remote scanning in a command center configuration and real-time remote expertise.
The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.
Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.
The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.