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Hologic, a provider of diagnostic imaging and state-of-the-art digital imaging
systems directed towards women's health, announced it has been awarded a three-year
dual-source contract with HealthTrust Purchasing Group (HPG), one of the nation's
healthcare group purchasing organizations.
Orthometrix announced at the International Foot and Ankle Congress in Toronto,
Ontario, that its new Orbasone Pain Relief System received a medical device
license (MDL) from Health Canada and may now be sold in the Canadian market
for treatment of chronic plantar fasciitis (foot pain).
Delcath Systems said its system for delivering high dose chemotherapy to specific
organs and body regions received fast-track status from the FDA for treating
metastatic melanoma in the liver with melphalan, a currently approved anticancer
agent.
Vision Sciences announced that it has received 510(k) clearance from the FDA
to market in the U.S. its new ENT-3000, a portable flexible nasopharyngoscope
with BLS-1000, a battery-powered LED (light emitting diode) light source, to
the ear-nose-throat market.
Merit Medical Systems, a manufacturer and marketer
of proprietary disposable accessories used primarily in cardiology and radiology
procedures, announced that it received FDA clearance to market its Prelude introducer
sheath.
MRL, a Welch Allyn company, announced it is initiating a voluntary worldwide
recall of 597 AED20 automatic external defibrillators (AEDs) manufactured in
Buffalo Grove, Ill. between February and July 2004.
Jarvik Heart, a developer of advanced technology for the treatment of heart
failure, announced it has received CE mark certification for the Jarvik 2000
FlowMaker, a tiny left-ventricular assist device (LVAD) used to treat severe
congestive heart failure.
Cyberonics' request to market an implantable nerve stimulator for treating chronic
depression should be rejected by U.S. authorities, consumer group Public Citizen
said.
The FDA has posted a "firm safety alert" about problems with several
blood-glucose testing systems for people with diabetes made by a unit of Johnson
& Johnson.
BioniCare Medical Technologies has closed a Series C Convertible Preferred Stock
financing with a syndicate of U.S. and Japanese institutional investors.