Parents Should Not Have Their Infants Sleep On Head-Shaping Pillows, FDA Warns
The US FDA says the safety and efficacy of pillows to correct the shape of an infant’s head have not been demonstrated. The devices could pose a risk of serious harm to the infant, including death.
You may also be interested in...
The US FDA has received a significant increase in medical device reports associated with Philips DreamStation 2 machines, including fire, smoke, and burns.
The Klinrisk model, a new AI-driven tool developed to predict the progression of chronic kidney disease, proved highly effective in a recent study. The model’s scientific founder told Medtech Insight the novel technology has the potential to help healthcare professionals better identify patients most at risk.
Three years after joining, the US FDA announced its withdrawal from the Global Harmonization Working Party and intention to focus its work on medical device harmonization through its collaboration with the International Medical Device Regulators Forum.