While a number of US states are taking actions that could potentially ban or limit ethylene oxide (EtO) sterilization plants in their communities, the FDA, industry and others are raising the alarm that such moves could lead to a shortage of medical devices critical to patients.
As more US states attempt to shut down sterilization facilities that use ethylene oxide (EtO), industry and regulators are concerned about potential shortages to critical medical devices around the country.
State efforts to close facilities that use EtO have begun ramping up, including efforts by Georgia to temporarily shutter a...
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
There is considerable focus at present on how far notified bodies can go in helping position their clients to have as smooth a conformity assessment passage as possible. It is a fine balancing act for all involved, but a new document sheds some useful light.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
