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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.
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.