The loophole is part of something called the 510(K) pathway. Researchers found it's led to a family tree of medical devices, recalled for potential patient harm — from IV tools in the hospital to a ...

The U.S. Food and Drug Administration published a draft guidance this past week with regard to medical device cybersecurity. The draft guidance, "Cybersecurity in Medical Devices: Quality System ...

Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex technologies like pacemakers and infusion pumps. Given the wide range of risks and benefits, ...