Artificial intelligence and machine learning technologies have significant potential, but regulatory hurdles may stand in their way.
After prompting from the agency, Allergan issued a worldwide recall of its BIOCELL textured breast implants and tissue expanders.
A timely step toward ensuring patient safety through data-driven product development.
The G4 gives doctors an additional range of clip sizes, along with enabling real-time procedure assessment.
The agency is encouraging the industry to develop sterilization approaches that either don’t rely on ethylene oxide or reduce emissions from this method.
The electrical nerve stimulator is intended to reduce functional abdominal pain in patients 11–18 years old.
A recent project conducted by Northeastern graduate students looked at device recalls over the past five years and some of the common threads.
The use of such devices could result in patient injury or even death.
OPEQ is an important step in the center’s modernization of business processes.
Risks related to balloon deflation, fragmentation and detachment could lead to serious adverse events, including death.