The U.S. Environmental Protection Agency’s rulings on ethylene oxide emissions have drawn the ire of the device industry, but the chemical industry has weighed in as well.
The U.S. FDA warning letter to Globus Medical Inc., highlights some long-running concerns at the agency about medical device reporting practices, but the agency was keen to point to a problem with the company’s complaint trending practices.
The U.S. National Institutes of Health sponsored a study that was designed to establish whether there are any biomarkers that are strongly associated with the constellation of symptoms known as long COVID, but the study shed little light on the question.
The U.S. FDA draft guidance for enforcement of in vitro diagnostics for emergent threats without a public health emergency has proposed some significant restrictions, which drew several negative responses.
The U.S. FDA’s draft guidance for in vitro diagnostics under a Section 564 public health declaration broke little new conceptual ground, but the Association for Molecular Pathology (AMP) urged the agency to reconsider the COVID-19 experience.
Minneapolis-based Smiths Medical Inc., recalled two entries in the company’s CADD-Solis line of ambulatory infusion pumps due to problems with the preloaded software.
The U.S. CMS announced the release of the Transitional Coverage for Emerging Technologies policy, which is less than clear on the definition of a key term.
The U.S. FDA’s discussion paper for health equity for medical devices reiterates standing policy on clinical trial enrollment, such as that the device’s pivotal study should be reflective of the intended use population.
The U.S. FDA’s program to foster at-home health care is in its early stages and seeks to promote the development of technologies that will enable home health care services.
The European Medicines Agency seems focused on pharmaceuticals to the near exclusion of medical technology, but the agency recently reported the launch of a pilot program for orphan medical devices.
