FDA provides 510(k) clearance for Neurologica's inSPira HD system

Sep 1 2009

NeuroLogica Corporation announced today at the XIV World Congress of Neurological Surgery in Boston, MA, receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its portable high resolution SPECT system: inSPira HD (www.inspirahd.com).

The inSPira HD is a battery powered, high resolution, portable SPECT designed primarily for brain imaging. Its unique capabilities provide the highest quality SPECT images wherever needed, including the Clinic, ICU, OR and Emergency Department. inSPira HD is capable of imaging any radioisotope energies between 80 – 200 keV for clinical applications such as Epilepsy, Parkinson’s, Stroke and Alzheimer's Dementia. Features such as high resolution, convenience, portability, and versatility set the inSPira HD apart from any other SPECT imaging system available today.

Traditional systems whose basic principles have been around since the 1960’s continue to suffer from poor spatial and contrast resolution. This has led to the term “fuzzy” imaging with 5-10mm spatial resolution in any one axis. The inSPira HD is revolutionary because it presents an entirely new method of SPECT detection, acquisition, and reconstruction which has been designed to approach 3mm spatial resolution.

“The medical community demands and deserves higher spatial and contrast resolution,” says Dr. Eric M. Bailey, President and Chief Executive Officer of NeuroLogica. “And we are pleased to provide that capability at a price point that makes sense in today’s economic environment. The inSPira HD is an entirely new type of SPECT imaging and will play a key role in the treatment of neurological diseases going forward.”

Dr. Colin Timothy McDonald, NeuroLogica’s Chief Medical Officer, stated, "We are grateful for the cooperative efforts among the FDA in granting approval of our portable high resolution SPECT: inSPira HD. The system is designed to push the limits of functional imaging in the human brain. Chronic neurological diseases such as Epilepsy, Parkinson’s Disease and Alzheimer’s Dementia are difficult to study with traditional 3D non-functional neuroimaging modalities. This is because their pathophysiology involves subtle and at times, submicroscopic disturbances of form and function. The development of radiopharmaceuticals that can specifically target these disease processes has caused a renewed interest and enthusiasm in SPECT and PET functional neuroimaging. NeuroLogica Corporation, along with its Medical Advisors, believes that the inSPira HD will prove absolutely necessary for making the qualitative and quantitative measurements necessary to determine the presence or absence of chronic neurological disease.”

http://www.neurologica.com