These infusion system replacement batteries were recalled because a defect has diminished how long they can be used to run the system, which may cause the system to shut down an ongoing infusion.
The new CONNEQT Pulse arterial health monitor provides measurements of both brachial blood pressure and central blood pressure.
The FDA granted marketing authorization for a device that recognizes when someone experiences opioid-induced respiratory depression.
Lydus Medical received FDA clearance 510(k) for a microvascular anastomosis suture deployment system for standardized omni-vessel anastomoses.
Sedgwick released its 2023 Product Recall Index, which detailed why defective and violative products reached a record-breaking high.
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The U.S. FDA is now accepting comments from the public on the draft guidance, “Remanufacturing of Medical Devices,” and on a discussion paper on cybersecurity servicing of devices.