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, midface, dorsum of the hands and the chin, infra-orbital hollows, jawline, and fine lines everywhere….
Expertise: MedTech 36 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 such as sensitivity, specificity, and positive predictive value, with outcome measures focusing on diagnostic performance….
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.
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 most importantly, for patients in need of life-changing therapies. Ironically, on examination, the causes for…
Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantable devices such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help monitor and treat patients. Before a medical device can be put on the market,…
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 investigational devices might be covered not only to offset the cost of development, but also…
An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect data on its safety and effectiveness.1 This exemption applies to the conduct of trials necessary for developing new medical devices. Most often, clinical studies are conducted to support a Premarket Approval (PMA) application, though some 510(k) submissions…