Despite how it sounds, a xenotransplant isn't something from the latest Alien movie. It's an increasingly credible science: the transplantation of animal organs into humans. The field took one of its biggest leaps forward on Monday. The FDA approved the biotech company eGenesis to begin human trials of pig-to-human kidney transplants.<br /> eGenesis provides pigs with CRISPR-modified genes. These genetic changes reduce the chances of organ rejection in human recipients. The FDA approved the company for Investigational New Drug (IND) Clearance for a three-phase study. Each stage will increase the number of patients if the results support moving forward.<br /> Only those with end-stage kidney disease will be eligible. They'll also need to be 50 or older, dialysis-d [...]
The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we're living in a time of widespread disinforma [...]
Artificial intelligence agents powered by the world's most advanced language models routinely fail to complete even straightforward professional tasks on their own, according to groundbreaking re [...]
Current and former members of the FDA told CNN about issues with the Elsa generative AI tool unveiled by the federal agency last month. Three employees said that in practice, Elsa has hallucinated non [...]
The Food and Drug Administration has approved a new device called the Teal Wand, which its creator describes as an "at-home vaginal sample self-collection device for cervical cancer screening.&qu [...]
Nuance Audio, new "hearing glasses" from EssilorLuxottica, have received FDA clearance and "a CE marking under the Medical Devices regulation in the EU," making them officially rea [...]