A loose cable found in certain models of GE anesthesia machines has resulted in the highest recall alert from the US FDA. Regulators are warning the mechanical problem could result in organ failure and even death.
The US Food and Drug Administration has issued a high-risk class I recall for GE Healthcare's Carestation 600 anesthesia systems due to a mechanical problem found in the devices that could cause serious harm to patients – and potentially be fatal.
The machines are meant to help children and adult patients undergoing anesthesia with breathing support. They are used by hospitals,...
16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
