The US Food and Drug Administration has granted Abbott emergency use authorization for its monkeypox test, making it the first diagnostic to detect the virus to become commercially available.
The US FDA has issued its first emergency use authorization (EUA) for a commercial monkeypox diagnostic to Abbott Molecular for its Alinity m MPXV real-time polymerase chain reaction (PCR) test that uses a lesion swab to detect the virus.
Though the FDA granted an EUA to Quest Diagnostics for its monkeypox PCR test in September, it was not for...
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.
The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.
Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
