FDAnews Device Daily Bulletin

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.