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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.
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.
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.
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.
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.