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Medical Services International announced that it has been awarded a $25 million
contract from the Federal Government of Nigeria for its VScan HIV 1&2 Test
Kits.
Xenogen announced a partnership with MIR Preclinical Services (MIR), a contract
research organization, for the purchase and sublicense of Xenogen's biophotonic
imaging, or real-time in vivo imaging, technologies.
MedicalCV, a cardiovascular surgery device manufacturer, focusing on the surgical
needs surrounding atrial fibrillation, announced the completion of a series
of U.S. human clinical cases using the AtriLaze Surgical Ablation System.
Cambridge Heart announced that it has received clearance from the FDA to begin
marketing in the U.S. its new Heartwave II System for the measurement of Microvolt
T-Wave Alternans (MTWA).
Animas, a manufacturer of insulin pumps, announced that it will be recalling
approximately 2,000 of the newly released IR 1250 pump due to a recently identified
software bug related to use of the food database.
Alliance Medical, a reprocessor of single-use medical
devices (SUDs), announced the FDA has cleared the final two 510(k)s filed by
the company in response to the agency's supplemental validation submission request.
Fresenius Medical Care AG, a provider of dialysis products and services, has
received FDA 510(k) clearance for the Liberty Cycler, an advanced device to
be used by patients who perform dialysis in the home setting.
Boston Scientific has begun enrollment in its clinical trial known as SYNTAX,
which will compare the performance of drug-eluting stents with cardiac surgery
in the most complex patient subsets: those with coronary artery disease in all
three coronary arteries, in the left main coronary artery, or both.
Abbott Vascular has submitted a premarket approval application to the FDA for
its StarClose Vascular Closure System, a next-generation vessel closure system
specifically designed for the simple, quick and secure mechanical closure of
femoral arteries following catheterization procedures, such as angioplasty and
stent placement.