Last month, the FDA scheduled a September panel meeting to take a hard look at Bayer's controversial birth control device, Essure, after getting complaints of clinical trial fraud and serious side effects tied to the product. Now, the agency is facing more pushback from women campaigning against the device, who claim that regulators purposely selected the panel meeting date to coincide with a visit from the pope.
Amid a growing body of research that shows deposits of gadolinium-based contrast agents (GBCAs) remain in the brain after repeat MRI procedures, the FDA is investigating the products' safety and risks.
Amid growing pushback over the number of fetal ultrasounds performed in the U.S., physicians are weighing in on the issue with recommendations as to how and when the procedures should be used.
Upstart Langford IC Systems claims that it's launching the only system that meets FDA standards for reprocessed medical device cleanliness. Its first buyer is the Ronald Reagan UCLA Medical Center in Los Angeles, which reported two patient deaths and several infections earlier this year due to insufficiently disinfected duodenoscopes, which are a type of endoscope for examining the duodenum.
On the heels of a permanent injunction from the Department of Justice that resulted in the cease of manufacturing at one of Maquet's facilities, the suspension of 5 of its devices from the market and a $6 million fine, the FDA just warned practitioners that the company's Flow-i Anesthesia Systems have a problem that "may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately."
Research presented at a European conference found that wearers of cardiac devices should keep a safe distance from smartphones.
The U.S. Food and Drug Administration has further formalized its ongoing review of the controversial Essure permanent birth control implant from Bayer.
Medtronic announced a large voluntary recall of its Shiley neonatal and pediatric tracheostomy tubes is underway due to a wider angle bend among affected models than in those manufactured after Nov. 29, 2012. It has suspended shipments of the faulty tubes.
The FDA warned of higher mortality rates among patients on SynCardia Systems' Total Artificial Heart Companion 2 Driver System who underwent certain preimplant interventions.
Royal Philips said it is working with ResMed to analyze study data from mid-May showing that the latter company's Adaptive Servo-Ventilation central sleep apnea treatment worsens cardiovascular mortality for those in a particular subset of chronic heart failure data. Philips has a similar device, which it said is contraindicated in the relevant population with increased mortality: moderate to severe central sleep apnea patients with symptomatic chronic heart failure and left ventricular ejection fraction of less than or equal to 45%.