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Specialized Health Products International (SHPI), a company specializing in
the design and development of medical safety devices, has received 510(k) clearance
from the FDA to market its next generation safety Huber needle, MiniLoc Safety
Infusion Set.
CeMines has filed a 510(k) application with the FDA seeking clearance for clinical
use of the company's first minimally invasive cancer detection kit, CeMines
CellCorrect LAb.
NIR Diagnostics, a developer of handheld reagentless medical instruments based
on its near-infrared light technology, announced that its 510(k) submission
for HemoNIRLAB (for laboratory use) has been awarded clearance by the FDA.
Breakaway Imaging, a developer of medical imaging
systems for surgery, said it received FDA 510(k) pre-market notification for
its mobile O-arm Imaging System.
MIV Therapeutics (MIVT), a developer of next-generation biocompatible stent
coatings and drug delivery technologies, has announced commencement of preclinical
trials of a unique proprietary filtration device designed to be implanted in
a main artery during cardiac procedures and heart surgery to divert particles
that might otherwise reach the brain and cause strokes.
Biophan Technologies, a developer of next-generation medical technology, announced
that its proprietary advanced solutions in the field of MRI safety present a
range of potential solutions to serious safety risks associated with the use
of MRI imaging of patients with implanted medical devices that have been widely
reported in the media.
DexCom announced it has received notification from the FDA that its PMA (premarket
approval application) for the DexCom Short-Term Continuous Glucose Sensor submitted
in March 2005 has been accepted as filed and granted expedited review status.
Mediscience Technology announced that its wholly owned New York subsidiary,
Medi-Photonics Development, has requested a formal meeting with the FDA to discuss
the CD-Ratiometer, an optical biopsy device as an adjunct to diagnosis for cancer
detection of the cervix and other abnormalities.
Biophan Technologies has executed a letter of intent (LOI) with German biomedical
researchers Arno Bucker and Alexander Ruebben for an exclusive license to their
breakthrough cardiovascular stent technology enabling accurate magnetic resonance
imaging (MRI) angiography of the interior of vascular stents.