Volcano Announces CE Mark and 510(k) Clearance for New Visions® PV .035 Digital IVUS Catheter

Volcano Corporation a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said today it has received clearance to market its new Visions® PV .035 Digital IVUS Catheter in both the US and Europe. The new intravascular ultrasound catheter is designed to image large vessels and facilitate the use of less iodinated contrast in endovascular procedures.

FDA Clearance For Siemens’ MAGNETOM Spectra 3T MRI System

Siemens Healthcare has announced that its MAGNETOM Spectra 3 Tesla MRI system has received US FDA clearance. The company believes it has achieved the optimal blend of reduced ownership costs, excellent image quality and rapid scan times with this system which it says provides hospitals and radiological institutes with easier access to 3T technology.

Bioptigen’s Envisu™ Becomes First OCT System FDA Cleared For Hand-held Paediatric Ophthalmic Imaging

Bioptigen Inc. has received FDA 510(k) clearance to begin marketing its hand-held Envisu Spectral Domain Ophthalmic Imaging System (SDOIS) for patient use. In receiving this regulatory clearance, Bioptigen’s Envisu SDOIS become the first optical coherence tomography(OCT) imaging system commercially available in the United States for hand-held and paediatric imaging.

GE Scanner Gains Fully Positive Recommendation From UK’s NICE.

GE Healthcare’s Discovery CT750 HD scanner has been included in the first ever fully positive recommendation from the UK’s National Institute for Health and Clinical Excellence (NICE)’s Diagnostic Assessment Programme, opening the door for increasing use of the technology in Coronary Artery disease assessment.