The FDA has cleared a new test from Fujirebio Diagnostics (Malvern, Pennsylvania) that is expected to help physicians assess whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of malignancy. Fujirebio says its HE4 test was cleared for use in the Risk of Ovarian Malignancy Algorithm (ROMA). (Medical Device Daily)

Guided Therapeutics (Norcross, Georgia), a developer of a rapid and painless testing platform that uses biophotonics for the early detection of disease, says it has answered all of FDA's key questions regarding the company's premarket approval (PMA) application for the LuViva Advanced Cervical Scan. (Medical Device Daily)

Graphene, a material already of interest in the world of nanotechnology, may become even more exciting as new research shows it has surprisingly powerful adhesion qualities, according to a group at the University of Colorado Boulder (CU-Boulder). (Medical Device Daily)

A new medical device designed to dramatically suppress uncontrolled bleeding in the groin and inguinal areas of wounded troops is being deployed to the battlefield. The Combat Ready Clamp (CRoC) is a vise-like tourniquet designed to manage difficult bleeds when hemorrhage control in tactical environments is not possible with traditional methods and standard tourniquets.

In an effort to get heart attack patients to the right treatment facility sooner, particularly in rural areas, Physio-Control (Redmond, Washington), a subsidiary of Medtronic (Minneapolis), has launched the ReadyLink 12-lead ECG device, a new FDA-cleared device designed to improve care for heart attack patients and expand regional STEMI systems. (Medical Device Daily)