LivaNova Recalls Blood Pump Device for Risk of Unintentional Extended Pump Stop
LivaNova is recalling the LifeSPARC Controller due to a software update being available to address a previous software malfunction.
LivaNova is recalling the LifeSPARC Controller due to a software update being available to address a previous software malfunction.
Lydus Medical received FDA clearance 510(k) for a microvascular anastomosis suture deployment system for standardized omni-vessel anastomoses.
The U.S. FDA has issued a draft guidance to help medical device manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting Program.
XACT Robotics, which offers a robotic system for interventional procedures, announces that the U.S. FDA has cleared its ACE Xtend Remote Control Unit, allowing users to robotically insert and steer the XACT ACE Robotic System remotely from the control room.
Philips has experienced thousands of complaints, lawsuits, criminal investigations, and a potential DOJ settlement related to CPAP recalls.
If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.
The U.S. FDA is now accepting comments from the public on the draft guidance, “Remanufacturing of Medical Devices,” and on a discussion paper on cybersecurity servicing of devices.