Tensions seem to be coming to a boiling point between Alere Inc. and Abbott Laboratories. After months of seeming waffling on the part of its suitor, Waltham, Mass.-based Alere, a developer of rapid diagnostic tests, is turning to the courts to force Abbott to follow through with its proposed $5.8 billion merger agreement.

Irvine, Calif.-based Lombard Medical Inc. (NASDAQ: EVAR) has hit the pause button on its U.S. operations, company executives confirmed this week, citing an unexpected roadblock erected by the FDA. In addition, Lombard, which focuses on the minimally invasive treatment of abdominal aortic aneurysms (AAAs), is mulling strategic alternatives, including a sale.

Three entities representing the medical device and imaging communities are heralding a tentative agreement with the FDA for the fourth reauthorization of a medical device user fee program.

Edwards Lifesciences Corp. is poised to reap major benefits following the FDA's decision to expand the indications of two transcatheter aortic valve replacement (TAVR) devices. The company's Sapien 3 and XT transcatheter valves now will be an option for patients who are at intermediate risk for death or complications associated with open-heart surgery.

In a move aimed at helping to reduce surgical complications, such as pain and bleeding, San Mateo, Calif.-based Levita Magnetics has released a magnetic surgical system for gallbladder removal after gaining de novo clearance from the FDA.

Germantown, Md.-based Senseonics Holdings Inc. (NYSE-MKT:SENS) is touting positive results from a study of its Eversense implantable continuous glucose monitoring (CGM) system, reporting that the technology demonstrated "strong accuracy" over 90 days of uninterrupted wear. The news comes as the CGM arena heats up, with Dublin-based Medtronic plc, San Diego-based Dexcom Inc., and others looking to make a splash.

In a historic move, the Centers for Disease Control and Prevention has issued a warning for those living in or traveling to a Miami neighborhood after the Zika virus was detected and spreading. Included in this warning is a recommendation that pregnant women be tested for the virus. How have diagnostics players stepped up to protect this — and other — vulnerable populations?

In a historic move, the CDC has issued a warning for those living in or traveling to a Miami neighborhood after the Zika virus was detected and spreading. Included in that warning is a recommendation that pregnant women be tested for the virus. How have diagnostics players stepped up to protect this – and other – vulnerable populations?