Many device manufacturers don’t have the resources to adequately handle security risks.
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.
Medical device recalls were at their lowest quarter since Q4 2011, according to Stericycle’s recall index for Q4 2017.
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.
A manufacturing error could cause chamber parts to split into layers and cause water to back up into the patient breathing circuit.
It’s good news for device companies, but industry associations and stakeholders are still seeking a permanent solution.
FDA has released a MedWatch Safety Alert about an issue with the LifeVest that can lead to a failure to deliver treatment.
The program aims to ensure that life-saving devices are available in battlefield settings.