NeuroLogica Corporation has received the 510(k) clearance from the FDA for the SPECT (single photon emission computed tomograph). The inSPira HD is a mobile system that runs on batteries and can be moved around hospital wards if necessary. Image quality of inSPira HD is close to that of PET with the resulting reconstructed spatial resolution as high as 3.0mm. inSPira HD is capable of imaging all available neuro radiotracers offering a broad range of clinical applications including Epilepsy, Parkinson’s, Stroke and Alzheimer’s.

A team of researchers led by Massachusetts General Hospital (MGH) radiologists has developed a computed-tomography-based protocol that identifies both narrowing of coronary arteries and areas from where blood flow to heart muscle tissue is restricted, giving a better indication of clinically significant coronary artery disease. Their report appears in the September 15 issue of the Journal of the American College of Cardiology. Ricardo C Cury, MD, a cardiac imaging specialist at the MGH Heart Center and the study’s principal investigator said “This is among the first demonstrations of the use of cardiac CT [computed tomography] to detect both coronary artery stenosis and resulting myocardial ischemia simultaneously in a single examination.”

Hologic, a developer of medical imaging systems and surgical products, has received the FDA’s clearance for its 510k application for the MammoSite ML radiation therapy system. With its multi-lumen design, this new device enables radiation oncologists to shape the radiation dose for typical cases and treat patients who are otherwise not appropriate candidates for traditional brachytherapy.

SuperSonic Imagine has received 510K clearance from the FDA for its Aixplorer(TM) ultrasound system. Aixplorer is the only commercially available system of its kind with MultiWave(TM) Technology, which is based upon interaction between conventional longitudinal waves and shear waves in tissue. The system displays tissue stiffness or elasticity information using shear waves. As stiffness is an additional parameter which characterizes tissue, Aixplorer brings clinicians significantly enhanced diagnostic information.