The non-invasive trigeminal nerve stimulation system is intended for patients seven to 12 years old.
Manufacturers of the surgical mesh devices have not provided reasonable assurances of safety and effectiveness, according to the agency.
Strong evidence of proper cleaning and reprocessing that eliminates the spread of bacterial infections is still not there, and improvements are necessary, says Shuren.
This new pathway is a considerable change for the medical device industry.
Although designed for software, Agile’s fundamental values are equally relevant to medical devices.
Domas to share her insights at the MedTech Intelligence Cybersecurity conference in June 4–5 in Boston.
Pharmaceutical companies have long been subject to the kinds of rigorous electronic reporting standards that will soon affect medical device manufacturers. What can be gleaned from their experiences?
Viant Medical’s Grand Rapids, MI facility was hit with violations from the Michigan Department of Environmental Quality.
It’s time to embrace new technology and promote standardization to raise best practice protocols.
Improving healthcare cost, quality and outcomes through analytics: Perspectives from key stakeholders.