MedTech
Expertise: MedTech 36 results
MedTech
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MedTech
Nach Davé
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 announced phaseout policy, the FDA is moving toward full regulatory control of LDTs. By February…
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 Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). The FDA, though…
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 for assessing the long-term behavior of a device and ensuring that the risk-benefit profile remains…
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 accurate, real-time data. In addition, government organizations, associations, and agencies are encouraging the use of…
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 percent of medical decisions are based on the results of these tests.1 Thus, diagnostic tests—and…