Abiomed’s Impella 2.5 Wins PMA Approval
The device, originally cleared under a 510(k), was reevaluted under the 515 Initiative and is now the first hemodynamic support device with a PMA indication for use during high-risk percutaneous coronary interventions.
Wireless Security: A Work in Progress
The keys to developing secure wireless infrastructures in the medical device industry are implementing solid risk-assessment and risk-management programs.
Hashing Out Patent Reform Options
A number of bills have been proposed to try to curb the patent litigation abuse that has impacted many industries, including medtech, but which one achieves the right balance?
Societies: Do More for Insulin Pump Safety
A joint statement from the European Association for the Study of Diabetes and the American Diabetes Association calls for more research and data transparency around real-world use of insulin pumps.
Get More Out of Pumping Less
A syringe pump driven by a servomotor outperforms standard stepper motor–driven syringe pumps in microdispense lab applications.