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The FDA has issued a nationwide alert against the use of all IV Flush brand
preloaded syringes containing either heparin or sodium chloride because the
products have not received proper clearance and may be contaminated.
Spire has announced the receipt of a two-year SBIR Phase II grant of $498,764
from the National Science Foundation to continue the development of blood-compatible
dialysis catheters, used for the treatment of end-stage renal disease dialysis
patients.
Infectech has received notification from the FDA's Center for Devices and Radiological
Health of registration of the company and its initial product line for biophasic
system devices.
Angiotech Pharmaceuticals has announced that it,
along with corporate partner Boston Scientific, has initiated legal proceedings
in the Netherlands against Conor Medsystems.
Southwestern Medical Solutions has announced that the company's design team
has begun to advance the technical elements for a carotid endarterectomy shunt.
FlowMedica, a medical device company developing intravascular systems for treating
renal dysfunction related to cardiovascular diseases, has announced Scripps
Clinic's initiation of a physician-directed clinical study of its FlowMedica
Benephit Infusion System in patients with compromised kidney function who are
undergoing coronary procedures.
IOMAI, a private biopharmaceutical company, has announced the award of a $2.9
million grant from NIH to help develop a patch that is designed to improve responses
to influenza vaccination.
Aspect Medical Systems has extended a distribution agreement with Boston Scientific
because further studies are needed to assess the use of its technology, which
monitors patients' consciousness during surgery, in less-invasive procedures.
Gebauer, a 106-year-old medical device manufacturer and marketer of topical
anesthetic skin refrigerants, has announced the formation of a new business
unit, the Medical Device Development and Contract Manufacturing Group.
Micro Therapeutics (MTI) has received a $3.7 million payment resulting from
the acquisition of certain assets of Genyx Medical, a company in which MTI held
a minority equity interest, by C. R. Bard.