If not used properly the test can mislead some patients that they do not have the coronavirus. The US FDA says health care providers should consider using another test if patients get a negative result.
One of the first COVID-19 tests to gain emergency use authorization (EUA) from the US Food and Drug Administration could be giving false-negative results if not used properly, the agency says.
The FDA issued on 4 January a safety communication for Curative Health Services Inc.’s SARS-CoV-2 molecular diagnostic test. The...
In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
GE HealthCare is pursuing a dual-front imaging strategy with its PET MIP agent Flyrcado for detecting artery disease: It lasts longer than current PET scan tracers and allows patients to do treadmill-based stress tests alongside the scan.
DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.
In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
GE HealthCare is pursuing a dual-front imaging strategy with its PET MIP agent Flyrcado for detecting artery disease: It lasts longer than current PET scan tracers and allows patients to do treadmill-based stress tests alongside the scan.
