FDA may need to revisit its upper-end limits for ultrasound scans and a 2008 guidance
addressing use of fetal ultrasounds in light of a documented rise in the number of fetal ultrasounds expectant mothers currently...
A sharp increase in the use of fetal ultrasounds in recent years in women with healthy pregnancies from an average of 2 scans to 5 scans per pregnancy and recent warnings from medical societies could prompt FDA to look more closely at possible risks to the fetus from ultrasound.
FDA may need to revisit its upper-end limits for ultrasound scans and a 2008 guidance
addressing use of fetal ultrasounds in light of a documented rise in the number of fetal ultrasounds expectant mothers currently...
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.