The U.K. Medicines and Healthcare products Agency (MHRA) is calling for more research into the vaginal microbiome as a way to redress the historic under-representation of women in clinical studies, which it said has contributed to “critical shortcomings” in understanding of female-specific conditions.

The largest genome-wide association study to date of myalgic encephalomyelitis/chronic fatigue syndrome has identified eight genetic loci that are significantly associated with the chronic debilitating condition. Onset of ME/CFS often is traced back to an infection and four of the loci involve genes that are expressed in response to viral or bacterial infections.

In less than two weeks, Setpoint Medical Inc. mastered the power serve with the first approval of a neuroimmune modulation device to manage rheumatoid arthritis, followed by a $25 million second tranche of its series C and a $115 million series D financing round.

Eleven pages is relatively short for a modern U.S. FDA draft guidance, but two trade associations nonetheless had questions about the FDA draft for transfers of 510(k) devices, such as how the agency defines the holder of the 510(k).

A research team from Pusan National University has developed a novel deep learning model coined Moglo-Net, designed to enable three-dimensional reconstruction of images from hand-held ultrasound procedures.