Tiger Tech’s COVID Plus Monitor is the first of its kind and could be crucial in identifying potential asymptomatic SARS-CoV-2 carriers in order to isolate them as the US economy starts reopening while the pandemic rages on.
A first-of-its-kind machine learning-based coronavirus screening device has gained emergency use authorization (EUA) from the US Food and Drug Administration. The product could be key to quickly and cheaply identifying people with COVID-19 as schools and workplaces reopening during the pandemic.
The FDA on 22 March announced that it gave marketing authorization to Tiger Tech’s COVID Plus Monitor. The device...
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
