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DiaDexus has announced submission of a 510(k) Premarket Notification to the
FDA seeking marketing clearance for the PLAC test as an in vitro diagnostic
product to help predict the risk for ischemic stroke.
SmartPill Diagnostics, developer of the SmartPill Capsule -- a noninvasive,
ingestible medical device that captures biomedical data from within the patient's
GI tract - has announced that 510(k) clinical trials of its SmartPill ACT-I
Capsule and GI Monitoring System are now underway at Massachusetts General Hospital.
VISX has announced it received approval from the FDA to market and sell Iris
Registration technology, the first fully automated method of aligning and registering
wavefront corrections for CustomVue treatment.
Paradigm Medical Industries has announced it has been awarded the CE Mark for
a new generation ultrasound biomicroscope (UBM), enabling the company to market
the device in 19 Western European countries and some parts of the Pacific Rim.
Palomar Medical Technologies announced the VisiLux1064 Laser Handpiece and the
LuxIR Infrared Handpiece for the Palomar StarLux Pulsed Light and Laser System,
and the DermaType Skinphotometer, presented at the American Academy of Dermatology's
63rd Annual Meeting in New Orleans.
PTC, the Product Development Company, announced the general availability of
the PTC Medical Device Template, combining leading, industry specific capability
and consulting expertise.
Researchers at Oregon Health & Science University's Advanced Imaging Research
Center (AIRC) are developing a new imaging method that may provide a clearer
diagnosis of breast cancer.