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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.
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.
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.
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.
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.
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.
Cardiac Science announced that physicians at the University of Michigan (UM)
Cardiovascular Center have launched a prospective study designed to assess the
effectiveness of the company's patented fully-automatic hospital bedside monitor-defibrillator,
the Powerheart Cardiac Rhythm Module (CRM), against the traditional hospital
"code blue" emergency response protocol.
HealthTronics announced that it signed a new $125 million Senior Secured Term
Loan B, due 2011, and a definitive credit agreement for a new five-year $50
million revolving credit facility, due 2010.
Medical-test maker Dade Behring Holdings said it will enter into a new, multiyear
agreement with a consortium of banks to provide a $600 million revolving credit
facility for the company.