In a 28 March FAQ document, the US agency cautions manufacturers on the 3D printing of medical devices to address the shortage of ventilators and other medical supplies during the coronavirus pandemic.
As the nation’s health care workers grapple with the rising demand for key medical supplies during the COVID-19 pandemic – including ventilators, face masks and face shields – 3D-printing companies such as HP Inc. and FormLabs, as well as research teams, have mobilized their efforts to meet the supply and keep health care workers safe.
As these efforts continue, the US Food and Drug Administration issued on 28 March a FAQ document cautioning that...
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.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
