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 Clears Toshiba’s Aquilion™ RXL CT System: New Technology Means Radiation Dose Reduction For Clinicians And Patients

Toshiba America Medical Systems, Inc. has received FDA clearance for its Aquilion™ RXL Edition CT system. The Aquilion RXL reconstructs images faster and includes the latest dose reduction technologies, providing what Toshiba says is faster, safer information to physicians and patients.

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.

FDA 510(k) Clearance for ViewRay’s MRI-Guided Radiation Therapy System

Cleveland medical device company ViewRay Inc., has received U.S. FDA 510(k) premarket notification clearance for its MRI-guided radiation therapy system. The ViewRay system features what the company calls a unique combination of radiotherapy delivery and simultaneous magnetic resonance imaging (MRI) for the treatment of cancer.

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.

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