• Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) reported it received a letter from the FDA requesting additional analyses and data for its Humanitarian Device Exemption (HDE) marketing application for the Andara OFS (Oscillating Field Stimulator) System, a nerve growth stimulator designed as a treatment for acute spinal cord injuries. Based on the FDA’s request for additional data and analyses, Cyberkinetics now expects that approval of its Andara OFS System for the treatment of acute spinal cord injury may be delayed until at least the first half of 2008. The Andara OFS System is intended as a treatment option for people with acute spinal cord injuries. The device is designed to be implanted in patients within 18 days following a spinal cord injury to stimulate nerves to grow across the area of injury. Though the device is removed after 15 weeks of treatment, improvement in both sensory and motor function may continue for months, even years, as nerves form new connections to transmit information to and from the brain.

• Cytori Therapeutics (San Diego) received 510(k) regulatory clearance from the FDA for the Cytori Autologous Fat Transfer (AFT) System. The system may be used to harvest, filter, and transfer a patient’s adipose tissue from one part of a patient’s body to another at the point-of-care in the same surgical procedure. “This is an important regulatory clearance toward a more comprehensive adipose tissue processing system,” said CEO Christopher Calhoun. “The key attribute of this device is its ability to optimize the preparation of adipose tissue before it is transferred back into the patient.” The Cytori AFT System is intended for use in plastic and reconstructive surgery, general surgery, neurosurgery, gastrointestinal surgery, urological surgery, orthopedic surgery, gynecological surgery, thoracic surgery and laparoscopic surgery.