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Fdanewsdevicedailybulletin

Jan. 25, 2005

Vol. 2 No. 17

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Cyberonics Submits Response to FDA Warning Letter

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.

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Advanced Biomaterial Receives FDA Clearance to Market Symphony

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.

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MedicalCV Completes First U.S. Case Using AtriLaze

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

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Bio-Matrix Retains Patent Attorney to Assist in Instrument Filing

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

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Device Shows Promise for Spinal Cord Injury

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.

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Fischer's MammoTest Cleared by FDA for Brachytherapy Platform

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

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DiaSys Enters Into Distribution Agreement With Chile's Galenica

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.

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CCL Unveils State-of-the-Art Picture Transmission Technology

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.

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Acceleration Therapeutics' AT-101 Reclassified by FDA

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.

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Surgical Innovations Looks to Egypt for Product Launch

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

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Zynex Medical Appoints Distributor in China

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

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Zevex to Introduce Next-Generation Enteral Feeding Pump

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.

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Intermagnetics Names Medical Devices Head

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

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The GlideAbout Corporation Introduces GlideAbout

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.

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