The mixture in some faulty Abbott PCR tests could cause COVID-19 positive samples to flow into neighboring negative samples, resulting in false-positive results.
Some Abbott Molecular Inc. Alinity COVID-19 laboratory tests may falsely diagnose patients with the SARS-CoV-2 virus. The US Food and Drug Administration says health care providers should consider redoing tests to decrease the chances of being misdiagnosed.
The FDA on 17 September said it has notified health care providers that the Alinity m SARS-CoV-2 AMP and Alinity...
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.
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?
