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BrainLAB, a company specializing in Image-Guided Surgery (IGS) and stereotactic
radiosurgery systems, announced the sale of BrainSUITE iMRI to The University
of Texas -- M.D. Anderson Cancer Center in Houston.
Halozyme Therapeutics said that it has received approval from the FDA to market
its first product, Cumulase, for use in the in vitro fertilization process.
Siemens Medical Solutions announced availability
of the MAGNETOM Trio magnetic resonance imaging (MRI) system with Tim (Total
imaging matrix) technology.
The FDA has granted 510(k) clearance for IRadimed's MRidium MRI Infusion Pump,
a nonmagnetic smart infusion system designed for the magnetic resonance (MR)
environment, enabling patients to receive intravenous medications safely and
continuously during the course of a scanning procedure.
Abbott has announced that its manufacturing partner Axis-Shield received 510(k)
clearance from the FDA for an automated sirolimus test for monitoring the therapeutic
levels of Wyeth's antirejection drug RAPAMUNE (sirolimus) in whole blood.
Underwriters Laboratories (UL) announced that the Japanese Ministry of Health,
Labor and Welfare (MHLW) has recognized its affiliate in Japan, Apex, as a third-party
certification body for active and implantable medical devices under the revised
Pharmaceutical Affairs Law (PAL) of 2002.
Medtronic announced that the European Commission has approved a spinal fusion
indication for InductOs, the surgically implanted product containing recombinant
human bone morphogenetic protein (rhBMP-2) that promotes new bone growth, or
bone regeneration.
Zonare Medical Systems, a medical device company developing a next-generation
ultrasound platform, announced the company has begun customer shipments of its
new z.one ultrasound system based on Zonare's breakthrough Zone Sonography technology.