Five More Deaths, FDA Alerts on Liquid-Filled Intragastric Balloons
This is the second alert the agency has issued in less than one year.
FDA Launches Innovation Challenge to Fight Opioid Misuse and Abuse
CDRH is urging the development of medical technologies and diagnostic tests that address pain, addiction and diversion.
Five Most Popular Articles of 2018 (So Far)
Here’s a hint: Compliance with new regulation in Europe is a high priority.
Medtronic Recalls MindFrame Capture LP Revascularization Device
There is a risk that the delivery wire could break or separate during use, being left inside the patient’s bloodstream as a result.
FDA Publishes FDARA Mandated Report on Servicing of Medical Devices
The report discusses the quality, safety and effectiveness of medical device servicing by OEMs and third parties.
Product Design Error Triggers Vyaire Medical Class I Recall
In the United States, the company has recalled nearly 360,000 AirLife Resuscitation Device and Broselow Convenience Kits due to a malfunction risk.
FDA Releases Draft Guidance for Multiple Function Devices
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
HSCA Releases Extensive Cybersecurity Considerations
The Healthcare Supply Chain Association releases a laundry list of areas in which device companies and providers must increase security of devices and networks.
J&J Restructure: Will Cost Cuts Affect Suppliers?
The company just announced that it is restructuring its global supply chain.
3-D Bioprinter Could Enable Large-Scale Printing of Artificial Human Tissue
For under $500, researchers have developed an open source bioprinter that they say is on par with machines costing significantly more money.
