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NeuroLogica Corporation Announces FDA 510(k) Clearance for inSPira HD: portable high resolution SPECT DANVERS, Mass.

 

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."

About NeuroLogica

NeuroLogica Corporation (www.neurologica.com) specializes in the design and
manufacture of cutting edge imaging equipment that is easy to use and bring the
power of imaging to the patient wherever they may be. The company's mission is
to bring high quality medical imaging to all people regardless of where they
live. NeuroLogica`s CereTom is FDA registered and the quality system is
certified to ISO 13485: 2003 and ISO 9001:2000 with Canadian Medical Device
Amendments. NeuroLogica`s CereTom is CE marked (European Conformity) for
distribution in the European Union and European Economic Area.

 

 

 

 



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