Counterfeit Devices Entering US Through Europe, FDA Officials Say
“Transshipment,” in which illicit devices are shipped to European hubs before being passed along to the US, has reportedly been on the rise since the start of the COVID-19 pandemic.
You may also be interested in...
The annual address also included discussion of legislation passed to improve the US supply of semiconductor chips, as well as new research body ARPA-H.
The ENT specialist reportedly purchased only 36 single-use sinus devices but performed at least 1,400 procedures. She could land up to 40 years in prison after being convicted on 20 counts including device adulteration, conspiracy, and fabricating medical records.
News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants
Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.