The Bio-Console 560 extracorporeal blood pumping console is being recalled over reports it could lose power during bypass surgery, which could lead to organ or neural dysfunction, blood clots, or even death.
The US Food and Drug Administration announced a high-risk class I recall of Medtronic Perfusion’s Bio-Console 560 extracorporeal blood pumping console on 20 April, marking the fifth recall of a Medtronic product since 1 March.
Medtronic is voluntarily recalling the device, which temporarily circulates blood during cardiopulmonary bypass surgery, following reports it could stop suddenly due to an electrical failure. Users also reported problems such...
Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.
Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
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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.
