The AI-enabled software automates whole-body tumor burden analysis for PSMA PET/CT and SPECT/CT studies to help clinicians assess treatment eligibility and monitor response.
The system brings surgical planning, real-time navigation, and robotic capabilities together in a single platform designed for spine procedures
A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
The clearance enables on-premise AI analysis of coronary CT angiography for quantifying calcified and non-calcified plaque.
GE HealthCare is updating use instructions after reports certain systems may not switch to battery mode during AC power loss, potentially disrupting ventilation and agent delivery.
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.