The U.S. Food and Drug Administration on Friday issued draft guidelines to medical device makers on how to protect patients from cybersecurity vulnerabilities in their devices. “Cybersecurity threats to medical devices are a growing concern,” the agency said in a …
America’s system for ensuring that medical devices are safe failed at every turn when dirty endoscopes began spreading deadly superbugs, according to a Senate investigation released today. The report, from Senator Patty Murray, a Washington Democrat, blames device manufacturers, hospitals, …
Mesh implants used to repair pelvic collapse in women will face new federal scrutiny, under rules responding to thousands of injuries reported with the problem-prone devices. The Food and Drug Administration said Monday that makers of pelvic mesh must submit …
The Obama administration wants you to eat your fruits and vegetables. They also want the produce to be safe. Long-awaited rules issued by the Food and Drug Administration Friday are designed to help prevent large-scale, deadly outbreaks of foodborne illness …
It’s a mistake to make a federal case out of a single outbreak of food poisoning. It’s worth pointing out, however, the utter failure of Congress to do more to prevent foodborne illness, which costs Americans some $15 billion in …
Federal health authorities are ordering manufacturers of specialized medical scopes to study how the reusable devices are cleaned following a series of life-threatening bacterial outbreaks at U.S. hospitals. The Food and Drug Administration said Monday that the three companies must …
Sweeping new rules meant to curtail foodborne illnesses that sicken one in six Americans each year will require food companies to create and follow new preventive safety measures, U.S. regulators announced Thursday. The rules require food companies to develop written …
Federal health officials laid out extra safety measures that hospitals can take to clean specialized medical scopes that have been linked to sometimes deadly bacterial outbreaks across the U.S. However, Food and Drug Administration officials acknowledged on Tuesday that not …
The U.S. Food and Drug Administration is turning to a patient-networking website to get a better handle on the side effects of medications. The FDA is tapping into a broad flow of data sent to PatientsLikeMe, an online site with …
Specialized endoscopes that are used to perform a common medical procedure have contributed to at least 13 deaths and 121 injuries in recent years by spreading bacteria among patients. A panel of medical experts at the Food and Drug Administration …