The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.

Meridian Bioscience, Inc. (NASDAQ:VIVO - News) has received clearance from the U.S. Food and Drug Administration (FDA) for its new molecular amplification assay, illumigene™ C. difficile.

AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems, has announced that it received clearance from the FDA for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion system. The AtriClip system is designed to safely and effectively exclude the left atrial appendage. Initial launch in the United States is anticipated to begin later this month with full commercial release planned during the third quarter of 2010.

AtriCure, Inc. has received conditional approval from the FDA to evaluate the safety and efficacy of a dual epicardial/ endocardial procedure (DEEP), or hybrid procedure, to treat patients with persistent and long-standing persistent atrial fibrillation (AF). The trial will be conducted at five prominent U.S. medical centers and provides for the enrollment of thirty patients. Initial enrollment is expected to begin during the second half of 2010.