NBC News reports that the FDA’s newly launched AI tool, named Elsa, is already having challenges addressing even simple tasks, such as uploading documents or answering questions from users. Further, the report says that the agency’s AI tool is not yet connected to the Internet, limiting its ability to access newly published studies. NBC’s sources say that Elsa “still needs significant work” to become operational.
The FDA initially announced that it would launch Elsa to help agency scientific reviewers and investigators “work more efficiently” by accelerating clinical protocol review and shortening the timeline for the execution of scientific evaluation.
According to a press release on the country’s government website, the new PMS regulations will require device manufacturers to proactively track the performance and safety of their products. The new regulations, which took effect on June 16th, apply to all UKCA- and CE-marked devices placed on the market after June 16th, including in vitro diagnostic devices (IVDs), active implantable medical devices, and other medical device technologies intended for use in healthcare settings and in-home care.
Specifically, the new PMS regulations will require medical device manufacturers to:
- Gather and assess data on how their medical devices perform in daily use, to help increase their ability to detect safety and performance issues;
- Expand incident reporting, including serious incidents relating to side effects associated with the use of their medical device;
- Leverage new data analysis reporting options to support earlier detection of trends; and
- More proactively assess and manage risks and promptly notify users when safety issues arise.
In a Report and Order, the Commission implemented a number of changes originally proposed in 2018, including the removal of 77 rules or requirements and eight forms the FCC deems “unnecessary.” Specific changes include:
- Deregulating cable equipment that is not used exclusively to receive the basic level of cable service;
- Deregulating small cable systems serving 15,000 or fewer subscribers;
- Declining to extend rate regulation to commercial establishments; and
- Revising and simplifying the process for cable operators to establish an initial regulated rate for services.
The latest action by the FCC is part of “Delete, Delete, Delete,” the Commission’s deregulation initiative, which it says is intended to “facilitate network modernization, infrastructure development, and performance innovation.”
The EU’s new “repairability score system” will soon be displayed on the EU’s new Energy Label that accompanies electronic devices. According to the Commission, “the repairability scores provide a clear and easy-to-understand rating of a product’s repairability from A (highest) to E (lowest).” Individual repairability scores consider several critical factors, including key product components, the steps and tools needed to disable a device and access replaceable components, and the availability of replacement information and spare parts.
The Commission says that the new repairability score system will provide consumers with information essential to understanding the environmental sustainability of new devices when they purchase them, allowing them to make more informed choices.
According to an article posted on the Penn State website, the team and their academic advisors designed a structure utilizing nonreciprocal emitters that can send emissions in different directions. Their breakthrough directly counters the long-standing premise that materials that absorb electromagnetic radiation at a given wavelength and angle must be equal to their capability to emit at the same wavelength and angle.
Zhenong Zhang, a doctoral candidate in mechanical engineering at Penn State, says that the team’s findings could be used to make the harvesting of solar energy even more efficient. “If we have nonreciprocal emitters,” says Zhang, “we can send emissions toward a different direction. Then, we could place another solar cell there to absorb this part of energy, increasing the overall power conversion efficiency.”
Linxiao Zhu, an assistant professor of mechanical engineering at Penn State, expanded further on the team’s research. “We designed a structure that has five semiconductor layers, each with slightly different compositions…the structure absorbs and emits thermal radiation over multiple wavelengths, so we expect to see the effect over a broad wavelength band.”
The results of the work conducted by the team were published in Physics Magazine.