The agency has issued a safety alert on the risk of bacterial infections linked to the use of LivaNova/Sorin's heater-cooler units during open-chest surgery, and held an advisory panel meeting last week to discuss strategies to better ensure safety of these and similar devices.
FDA highlighted reports linking the Stockert 3T heater-cooler from LivaNova PLC/Sorin Group SPA with infectious disease in heart failure patients last week and also convened a public hearing on the safety of this type of device.
Infection with the M. chimaera bacterium following cardiothoracic surgery using the 3T has been reported in US patients, according to a June 1 FDA safety alert. Researchers are trying to...
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
