The quest to maintain the appearance of youth has fueled widespread use of injectable dermal fillers—and a deeply competitive landscape. A host of approved products are readily available in the United States, used to ameliorate nasolabial folds, perioral lines, lips,...
Expertise: MedTech 32 results
Diagnostic research encompasses a wide array of tools, including medical devices, imaging techniques, and laboratory tests, all aimed at assessing the accuracy, safety, and effectiveness of diagnosing diseases or conditions. The primary endpoints in diagnostic trials typically test accuracy metrics...
Under the EU Medical Device Regulation (MDR), manufacturers are required to plan, conduct, and document a clinical evaluation in accordance with Article 61, part A of Annex XI.
Metabolic
Milena Kanova-Petrova, M.D.
As a sponsor wisely noted, “Clinical trials have nothing without participants.” Yet, in a 2023 study, 48% of sites cited patient recruitment and enrollment as a top challenge. The downstream impacts of recruitment challenges are profound for sponsors, sites, and...
Significant risk studies of medical devices require an investigational device exemption (IDE), which allows the device to be used in a clinical study to collect data on its safety and effectiveness.1 Often, device developers wonder whether—and how—the cost of those...