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.

ReCor Medical announced that the RADIANCE-HTN SOLO study met its primary efficacy endpoint and demonstrated a statistically significant reduction in blood pressure in hypertensive patients. In addition, the company announced submission of an investigational device exemption (IDE) supplement to the U.S. Food and Drug Administration (FDA) for a pivotal study of its Paradise System for the treatment of hypertension. Prof. Ajay Kirtane, M.D., of New York-Presbyterian Hospital/Columbia University has taken the role of co-principal investigator for RADIANCE-HTN.