About 25% of U.S. healthcare spending — between $760 billion and $935 billion annually — is wasted, according to a new report published today. Researchers from Humana (NYSE:HUM) and the University of Pittsburgh School of Medicine searched medical literature from January 2012 to May 2019, looking for waste and savings opportunities in six domains of […]
Study: Abbott, Edwards may have mislabeled hundreds of patient deaths
This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA […]
Appeals court gives NeuroGrafix another shot at Brainlab in patent dispute
A federal appeals court has reinstated a long-running MRI patent lawsuit that NeuroGrafix brought against Brainlab. Santa Monica, Calif.-based NeuroGrafix claims that Brainlab (Munich, Germany) infringed on an MRI imaging patent. Two lower courts had dismissed the suit, but a three-judge U.S. Court of Appeals panel ruled yesterday that the latest ruling was “procedurally improper” […]
ICU Medical recalls infusion sets
ICU Medical (NSDQ:ICUI) said today that it is recalling certain lots of its Plum and Sapphire microbore infusion sets with inline filters due to the potential for small amounts of fluid to leak from the filters’ air vents. San Clemente, Calif.-based ICU Medical said it is not aware of adverse events related to the problem, […]
Teleflex says infant breathing device it distributes is recalled
Teleflex (NYSE:TFX) today announced a recall of a device used to help newborns with infant respiratory distress syndrome to breathe. Teleflex is one of the U.S. distributors of the device, the Babi.Plus 12.5 cm H2O pressure relief manifold, manufactured by GaleMed. The FDA has designated the recall as Class I. The recall began June 14 […]
Medtronic appeals $24m patent loss to Supremes
Medtronic (NYSE:MDT) has asked the U.S. Supreme Court to overturn its nearly $24 million loss in a patent infringement lawsuit brought by a physician inventor. In February 2014, Dr. Mark Barry alleged that Fridley, Minn.-based Medtronic infringed on three patents covering a “system and method for aligning vertebrae in the amelioration of aberrant spinal column […]
Report: Docs could reduce adverse events with Boston Sci’s Watchman
This article has been updated to include comments from Boston Scientific. A recent review of FDA files has found nearly 3,000 adverse events related to Boston Scientific’s (NYSE:BSX) Watchman device. The Watchman left atrial appendage closure device, approved by the agency in March 2015, is designed to prevent blood clots that form in the heart’s […]
Study: Mechanical thrombectomy no better than best medical care for stroke
An international study and meta-analysis have found that mechanical thrombectomy and best medical management produce similar results in stroke patients with emergency large-vessel occlusion and mild resulting deficits. Up to 10% of patients with emergency large-vessel occlusion treated within six hours can have mild deficits and deteriorate rapidly or gradually, leaving physicians in a conundrum […]
BD Georgia sterilization plant leaked 54 lbs. of ethylene oxide in September
A weeklong valve leak at a Becton Dickinson (NYSE:BDX) medtech sterilization plant in Covington, Ga., released 54 lbs. of ethylene oxide into the air, according to a City of Covington incident report obtained by a local TV station. The plant began experiencing intermittent elevated levels of EO indoors Sept. 15, but inspections and systems checks failed to locate the […]
A ‘rolling effect’ on medtech sterilization plants?
The types of regulatory hurdles that contributed to the permanent closure this week of the Sterigenics medtech sterilization plant in Willowbrook, Ill., have created a “rolling effect” on ethylene oxide (EO) plants around the country, according to an industry official. The state of Illinois temporarily shut down the Willowbrook plant in February over emissions of EO, a […]
Australia suspends sales of certain textured breast implants
Australian health officials have suspended sales of some textured breast implants for six months and recalled models of those implants already distributed due to concerns about an uncommon form of lymphoma. The Australian Therapeutic Goods Administration (TGA) temporarily halted import, export and supply of eight models of breast implants following reports of about 100 cases […]