MedTech
Expertise: MedTech 32 results
MedTech
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For decades, laboratory developed tests (LDTs) have operated under minimal FDA oversight, but advancements in molecular biology, the rise of personalized medicine, and the critical role of diagnostic testing have prompted the FDA to revise its approach. In its recently...
Laboratory-developed tests (LDTs) have played a critical role in healthcare for decades, providing clinicians with diagnostic insights tailored to specific patient needs. Historically, these tests, developed and used within individual laboratories, have operated under the oversight of the Centers for...
Post-market clinical follow-up (PMCF) activities are necessary for continuously monitoring the clinical benefits, performance, and safety of medical devices after they have been released on the market. As part of a broader post-market surveillance (PMS) strategy, these activities are crucial...
In vitro diagnostics (IVDs) have become a cornerstone of modern medicine, and rising demand for these critical medical devices has driven rapid market growth. Since 2021, hospitals and laboratories have demonstrated an increasing preference for point-of-care testing devices to get...
Laboratory developed tests (LDTs) and in vitro diagnostics (IVDs) play a critical role in modern medical care. According to the US Centers for Disease Control and Prevention (CDC), 14 billion laboratory tests are ordered each year and an estimated 70...