Biotronik announced that the U.S. Food and Drug Administration (FDA) has approved, with conditions, the ProMRI clinical trial via an Investigational Device Exemption. Biotronik is sponsoring the trial (NCT01761162) and has already initiated U.S. site recruitment. The ProMRI clinical trial is designed to recruit 245 subjects implanted with one of Biotronik’s cardiac devices that include ProMRI technology at 30 U.S. investigational centers.

January 21, 2013 — ECRI Institute, a nonprofit organization that researches the best approaches to improving patient care, recently evaluated evidence behind the use of the only transcatheter heart valve approved for marketing in the United States and Europe in transcatheter aortic valve implantation (TAVI).

The first patient has been treated in the Boston Scientific Corporation ZERO AF clinical trial to evaluate the safety and effectiveness of the Blazer open-irrigated temperature ablation Catheter in patients with symptomatic, drug refractory paroxysmal atrial fibrillation. This international, multi-center study will include up to 33 sites in the United States, Europe and Asia-Pacific, and as many as 472 patients. The results of the ZERO AF trial are expected to be used to support a U.S. Food and Drug Administration (FDA) regulatory submission for a paroxysmal atrial fibrillation indication.

GE Healthcare announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility. Optison is a contrast agent that may improve the visualization of the left ventricular border — an area of the heart that is critical to see in order to assess and diagnose certain heart diseases. Upon approval, GE Healthcare will provide supply of Optison to the U.S. market from its manufacturing facility in Oslo, becoming the only contrast media manufacturer to supply its own stock for the United States.

CardioMEMS Inc. has been honored as the 2012 recipient of the Intel Innovation Award. Founder and CEO Jay Yadav, M.D., was presented with the award on Dec. 4, 2012 during the annual Health IT Leadership Summit held at the historic Fox Theatre in Atlanta, Ga.

GSI Group Inc., a leading supplier of laser-based solutions, precision motion and optical technologies to global industrial, medical, electronics and scientific markets, announced that it has acquired NDS Surgical Imaging (NDS), a San Jose, Calif.-based global leader in surgical and radiology displays and related peripherals, for $82.5 million in cash, subject to customary closing adjustments.