FDAnews Device Daily Bulletin

Cyberonics has submitted its response to the FDA warning letter dated Dec. 22, 2004, regarding nonconformities with current good manufacturing practice requirements of the quality system regulation for medical devices, as specified in Title 21, Code of Federal Regulations, Part 820 during a meeting with the Dallas District Office.

Advanced Biomaterial Systems has received 510(k) clearance from the FDA to market ABS' Symphony VR Radiopaque Bone Cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

MedicalCV has completed the first U.S. human clinical case using the AtriLaze Surgical Ablation System, the company said.

Bio-Matrix retained a patent attorney to assist in preparing to file its first patent relating to stem-cell instruments.

An experimental device designed to regenerate nerve fibers in people with spinal cord injuries shows promise, says an Indiana University School of Medicine study in the January issue of the Journal of Neurosurgery.

Fischer Imaging recently received FDA clearance for use of the MammoTest Breast Biopsy System as a platform for interstitial breast brachytherapy.

DiaSys, a global diagnostics products company, has entered into an agreement with Galenica, the largest diagnostics distributor in Chile, to distribute its products throughout the country.

Technology developer Cambridge Consultants has unveiled a state-of-the-art wireless technology capable of transmitting pictures from miniscule, swallowable video cameras among a host of other next-generation medical applications.

Acceleration Therapeutics Division of Non-Invasive Monitoring Systems announced that the FDA reclassified the flagship product of the company, the AT-101 device, from its listed FDA Class 1 (exempt) powered exercise device to a therapeutic vibrator requiring 510(k) submission.

Surgical Innovations, which designs and makes innovative surgical devices, is to launch its Variglide port system in Egypt.

Zynex Medical has announced the appointment of Jilin Universal Medical Technologies as distributor of its line of electrotherapy products in mainland China.

Zevex will introduce its next-generation enteral feeding pump, the EnteraLite Infinity, associated disposable sets and a new line of carry packs at the American Society of Parenteral and Enteral Nutrition Annual Conference Jan. 30 through Feb. 1 in Orlando, Fla.

Intermagnetics General named Michael Mainelli to head its medical device business.

GlideAbout has introduced a new walking aid, the GlideAbout, a lightweight -- at 15 pounds -- and easily transportable scooter, designed specifically to improve the lives of individuals with certain mobility impairments.