We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA is reminding healthcare providers that pump thrombosis, strokes and bleeding events are complications that can result from using implantable left ventricular assist devices on certain heart failure patients. Currently, Thoratec and HeartWare are the only companies marketing such devices in the U.S. Read More
With a number of attempted and successful cyberattacks making headlines, what steps can medical devicemakers take to ensure the security of their products? Read More
Medtronic is providing diabetic Australian patients with updated instructions for use for its portable MiniMed 640G insulin pump after identifying the potential for user error. Read More
The FDA is giving labelers of intraocular lenses the green light to restart submissions to the Global Unique Device Identification Database after extending the deadline by one year over data concerns. Read More
TÜV Rheinland has scored another victory in a French court in a case involving faulty breast implants. However, its fate in another case is up in the air as it awaits a decision from the European Court of Justice. Read More
Public Citizen has filed a petition urging the FDA to rescind its approval of the Seprafilm bioresorbable membrane, which is used to prevent postoperative adhesions, citing adverse patient events, including at least 21 deaths. Read More
With a number of attempted and successful cyberattacks making headlines, what steps can medical devicemakers take to ensure the security of their products? Read More
Following more than 5,000 complaints including reports of patient injuries and four deaths, the FDA is taking a second look at the safety and effectiveness of Bayer’s Essure birth control implant. Read More