• AtriCure (West Chester, Ohio) said that its Coolrail linear ablation pen received FDA clearance for the ablation of cardiac tissue. The Coolrail linear ablation pen is designed to facilitate the creation of an expanded cardiac ablation lesion set during a minimally invasive off-pump procedure. The ORLab system is a mapping, recording and stimulating system which enables electrophysiologists and surgeons to confirm, in the operating room, that the cardiac ablation lines being created are forming electrical barriers, or lines of conduction block. AtriCure makes cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue.
• Ceragenix Pharmaceuticals (Denver) said that preclinical testing of the company’s CeraShield coated endotracheal has shown that CeraShield coated endotracheal tubes were able to provide a 7-fold increase in the duration of antimicrobial protection compared to the recently cleared silver coated Agento tube from C.R. Bard. Ceragenix is a biopharmaceutical and medical device company focused on infectious disease and dermatology.
• Power3 Medical (Houston) has commenced a 300 patient clinical validation study of its NuroPro diagnostic test for Alzheimer’s disease (AD) and Parkinson’s disease (PD). The clinical validation study will be a blinded study of Power3’s NuroPro diagnostic test, which is a blood test for the detection of AD and PD. The NuroPro is based on Power3’s discovery of a group of fifty-nine proteins in the blood that demonstrate significant differences in blood serum concentration for patients with AD and PD. In blood serum, these protein biomarker combinations, when measured by blood serum proteomics, will lead to a more effective diagnosis and treatment of AD and PD. Power3 Medical makes diagnostic tests for the early detection of breast cancer and neurodegenerative diseases.
• Visionsense (Orangeburg, New York) reported FDA clearance of the new VSII — Visionsense Stereoscopic Vision System. The system is based on a miniature 3.4 mm distal (“chip-on-a-stick”) stereoscopic 3-D camera targeting minimal invasive laparoscopic and endoscopic surgery (MIS). Visionsense’s stereoscopic 3-D camera enables and enhances MIS surgical procedures that are under served by traditional 2-D visualization, in markets such as: Spine, Neurosurgery, Orthopedics, Endoscopy, General Surgery, GYN, Robotics, and others. Visionsense makes customized miniature stereoscopic 3-D cameras/sensors that enable surgeons to see “natural” stereovision, thus enhancing image understanding and hand-eye coordination.