FDA issues safety notice for syringes made in China
Editor's Note The US Food and Drug Administration (FDA) issued a safety notice on November 30 regarding quality concerns related to several Chinese manufacturers of syringes. The FDA is evaluating these devices for potential problems, including leaks, breakages, and the presence of particles in the syringes. According to the safety…
FDA encourages new cybersecurity standards on medical device manufacturing
Editor's Note The US Food and Drug Administration (FDA) has recognized the latest guidance on medical device cybersecurity from the Association for the Advancement of Medical Instrumentation (AAMI), an AAMI November 14 press release reports. This latest cybersecurity recognition is encouraging its use across the medical device manufacturing industry to…
Steven Rosenberg, pioneer in immunotherapy, awarded National Medal of Technology and Innovation
Editor's Note Steven Rosenberg, MD, PhD, chief of the Surgery Branch at the Center for Cancer Research at the National Cancer Institute, part of the National Institutes of Health (NIH), and a pioneer in the development of immunotherapy to fight cancer, was awarded the National Medal of Technology and Innovation.…
AI brain implants allow paralyzed man to regain use of arms, hands, fingers
Editor's Note In a first of its kind surgical procedure, doctors have installed artificial intelligence (AI) implants in the brain of a 46-year-old man who was paralyzed from a fall on the ice, CNN September 27 reports. The AI implant formed a "digital bridge"–an idea pioneered by the French neuroscientist…
FDA: Class I recall of Mallinckrodt One-Way Valve, 22F x 22M
Editor's Note The Food and Drug Administration (FDA), on September 12, identified the recall by Mallinckrodt Manufacturing of its One-Way Valve, 22F x 22M, as Class I, the most serious. The recall was issued because the devices are not opening properly, which prevents or reduces the flow of ventilated air…
FDA approves updated COVID-19 boosters
Editor's Note The Food and Drug Administration (FDA), on September 11, approved the Moderna and Pfizer/BioNTech updated COVID-19 boosters that target the Omicron subvariant XBB.1.5, the September 11 Reuters reports. The boosters, which were approved for those 12 years and older and authorized for emergency use for children ages 6…
FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs
Editor's Note The Food and Drug Administration (FDA), on August 31, identified the recall by Getinge/Maquet/Datasocpe of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The FDA posted four recalls for four separate reasons: Because they may overheat when the device’s internal temperature…
LivaNova receives FDA 510(k) approval for new in-line blood monitor
Editor's Note The Essenz™ In-Line Blood Monitor (ILBM) has received U.S. FDA 510(k) clearance and CE mark, as announced by manufacturer LivaNova on August 30. The new ILBM provides “accurate and continuous measurement of essential blood parameters for perfusionists throughout cardiopulmonary bypass procedures,” and integrates with the company’s Essenz Perfusion…
FDA: Class I recall of certain Hamilton ventilators
Editor's Note The Food and Drug Administration (FDA), on August 30, identified the recall by Hamilton Medical of its HAMILTON-C1, C2, C3, and T1 ventilators as Class I, the most serious. The recall was initiated because of software issues that may cause the ventilators to stop without notice. There have…
FDA: Class I recall of Draeger Carina Sub-Acute Care Ventilators
Editor's Note The Food and Drug Administration (FDA), on August 23, identified the recall by Draeger Medical of its Carina Sub-Acute Care Ventilators as Class I, the most serious. The recall was initiated because of the presence of contaminants in the device’s airpath. The contaminants exceed acceptable levels if the…
Free Daily News
- HHS releases concept paper on cybersecurity for healthcare sector
- Study examines infection precautions during pandemic based on healthcare roles
- Postoperative opioid prescriptions falling, but more improvement needed
- New protein calculation uncovers which organs are aging at an accelerated pace
- Researchers are calling for better tracking of chronic diseases
- New Joint Commission certification addresses secondary use of data
- New wearable device system could aid in remote medical monitoring
- Looking more closely at nurse burnout, impact on quality care
- FDA issues safety notice for syringes made in China
- Online training program significantly reduces postop complications following colon surgery
