Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more
2/21/2023
/ Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Industry Standards ,
Food and Drug Administration (FDA) ,
Hackers ,
Hospitals ,
Innovative Technology ,
Internet of Things ,
Manufacturers ,
Medical Devices ,
Popular ,
Regulatory Agenda ,
Regulatory Standards
Medical device companies have for many years used 3D printing to create innovative products such as custom patient-matched devices and individualized anatomical models for surgical planning. Typically, these activities have...more
On May 10, 2016, FDA released a much-anticipated draft guidance (the “Guidance”) concerning medical devices that incorporate additive manufacturing (AM) technologies, a category which includes 3D printed devices. AM...more
On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more