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%.
The U.S. Department of Justice subpoenaed Olympus Medical Systems in the latest portion of the long-unfurling saga of how and why duodenoscopes routinely used in colonoscopies and upper gastrointestinal tract examinations have continued to be a problematic source for the spread of deadly bacteria for years.
Johnson & Johnson is facing more backlash over power morcellator devices used in minimally invasive gynecological procedures, as the FBI investigates how much the company knew about the products' risks before pulling them from the market last year.
St. Jude Medical suffered a rare withdrawal of the CE mark of its Portico transaortic aortic valve replacement last year and had to suspend its U.S. clinical trial for FDA approval. Now new data released from three studies at the annual EuroPCR conference in Paris should help St. Jude convince the FDA to resume that trial.
In preparation for an upcoming meeting on duodenoscope safety, the FDA revealed it's received 142 reports of contaminated duodenoscopes since 2010.
As the industry and regulators respond to public outcry over power morcellators used in minimally invasive gynecological procedures, one of the U.S.'s largest health insurers is curtailing its coverage of the device.