Datascope/Getinge has initiated yet another recall of its Intra-Aortic Balloon Pumps, this time because of a communication loss between the circuit board and video generator. The FDA has given this recall a class I designation.
Getinge subsidiary Datascope has launched yet another recall of its Intra-Aortic Balloon Pumps (IABPs), which are used to provide temporary support to the left ventricle during surgery. This comes only a few weeks after the most recent recall announcement but relates to a different problem.
The latest recall, initiated by the firm on 9 January, includes the Cardiosave Hybrid and Cardiosave Rescue models – the...
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.
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
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?
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
