FDAnews Device Daily Bulletin
March 29, 2005 | Vol. 2 No. 62
Medtronic has announced that the FDA designated Activa Deep Brain Stimulation (DBS) Therapy as a humanitarian use device for the treatment of chronic, treatment-resistant obsessive compulsive disorder as an alternative to anterior capsulotomy, a form of destructive, irreversible neurosurgery.
The FDA has given 510(k) clearance for Instrumentation Laboratory's (IL) HemosIL D-Dimer assay, clarifying the product's intended use and introducing new data from a management study in the product insert.
Datascope has entered into an agreement with W.L. Gore & Associates under which Gore will become the exclusive distributor of Datascope subsidiary InterVascular's full line of polyester grafts and patches in the U.S., effective May 1.
CardioTech International announced that its wholly owned subsidiary, Gish Biomedical has received FDA clearance to sell a disposable soft shell venous reservoir that facilitates air removal during surgical procedures requiring extracorporeal support for up to six hours.
ThermoGenesis announced that Asahi Kasei Medical, a supplier of medical products and disposables and the exclusive licensed distributor of the CryoSeal System in Japan, has completed their premarket approval (PMA) submission to the Ministry of Health, Labor and Welfare (MHLW) following completion of their clinical trial on cardiovascular, orthopedic, neurosurgery and esophageal surgery patients.
Advanced Medical Optics (AMO), a developer of ophthalmic surgical devices and eye care products, added to its portfolio of refractive intraocular lenses (IOLs) with the announcement that the FDA has approved the ReZoom multifocal refractive IOL for cataract patients.
Using the most advanced 64-slice computed tomography (CT) technology available, clinical researchers at Beth Israel Deaconess Medical Center announced the completion of the world's first chest pain evaluation using Electrocardiogram-gated (ECG-gated) imaging performed with the Toshiba Aquilion 64.
AMS Homecare announced that it has entered into a binding agreement with Wireless 2000 of Burnaby, British Columbia, Canada, to acquire the exclusive distribution rights to distribute its products into the healthcare, residential elder care, medical offices and hospital markets in North America.
Two childhood friends have teamed up to produce the first vibrating teether, called the Je Je Teething Ring.
The Biomove 3000 system was specifically developed for home therapy following a stroke.
Imaging Diagnostic Systems (IDSI) announced that it has signed distribution agreements for 20 additional countries.
A startup that's developing a device to surgically treat arrhythmic heartbeats has hired a Triangle pharmaceutical industry veteran as its chief executive and is pursuing $8 million in first round venture funding.
IVAX announced it has entered into a strategic alliance with Pediatrix Medical Group to distribute the StepOne Newborn Screening Program developed by Pediatrix's subsidiary, Pediatrix Screening, throughout Latin America.
North American Scientific announced that it received notice from the Nasdaq Stock Market stating that it's in danger of being delisted due to its failure to timely file its latest quarterly financial report.
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