The U.S. Food and Drug Administration (FDA) is issuing a proposed order to reclassify certain radiological medical image analyzers, or computer-aided detection (CAD) devices, from class III to class II devices. This includes CAD devices for mammography breast cancer, ultrasound breast lesions and radiograph lung nodules.

Late-breaking trial results presented at the EuroPCR Congress, May 21-24 in Paris, France, found the Optimax titanium-nitride-oxide (TiNO)-coated Optimax stent was superior to the Synergy everolimus-eluting stent (EES) in acute coronary syndrome (ACS) patients. Results were presented by Pasi Karjalainen, M.D., Heart Center, Satakunta Central Hospital, Pori, Finland.

Two-year outcome data from the BIO-RESORT randomized controlled trial were presented in a late-breaking clinical trials session at EuroPCR 2018, May 21-24 in Paris, France.

Data from the GENETIC-AF trial was presented in a “Late Breaking Clinical Trials” oral presentation at the European Society of Cardiology (ESC) Heart Failure 2018 World Congress, May 26-29 in Vienna, Austria. William T. Abraham, M.D., professor of medicine, physiology and cell biology and director, Division of Cardiovascular Medicine at the Ohio State University presented the data.