The Banyan Brain Trauma Indicator was authorized through the agency’s Breakthrough Devices Program.
A new conference providing practical approaches and best practices to medtech challenges will take place in Rockville, Maryland June 6–8.
How software is changing the legal landscape for medical device manufacturers.
The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.
The addition will further expand IPC’s event capabilities.
Human factor engineering must account for all groups within the Diffusion of Innovation curve. Medical devices must work for the Innovators, and more importantly account for the Majority Adopters and Laggards.
It’s good news for device companies, but industry associations and stakeholders are still seeking a permanent solution.
The program aims to ensure that life-saving devices are available in battlefield settings.
The jury is still out, according to an analysis conducted by Cedars-Sinai.
The agency found several violations during an inspection related to its investigation of inaccurate blood lead test results.