Siemens scores FDA OK for molecular system

AuntMinnie.com staff writers

Feb 18, 2008

Siemens Medical Solutions of Malvern, PA, has received U.S. Food and Drug Administration (FDA) clearance for its Versant 440 molecular system for use with Versant HCV RNA 3.0 assay for the management of patients with the hepatitis C virus (HCV) who are undergoing antiviral therapy.

Siemens' system for automated viral load testing is designed to enhance throughput and maximize productivity in clinical laboratories.

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Siemens receives CCHIT OK for Invision, February 1, 2008

Copyright © 2008 AuntMinnie.com

Individualized parametric z-score maps of the brain showing glial activity load in the brain, compared among individuals with secondary progressive MS (SPMS) (top row), relapsing-remitting MS (RRMS) (middle row), and a healthy control (HC) (bottom row) in transaxial, sagittal, and coronal sections. Image courtesy of Clinical Nuclear Medicine.

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Examples in two patients. (Top) Abnormal leukocyte accumulation was observed in the right 1st to 5th toes, with the radioactive lesions extending to the bone, indicating osteomyelitis (left panel, MIP image; right panel, axial SPECT/CT). Two spherical VOIs were drawn on diabetic foot infections (DFIs) and the highest SUVmax was 4.2 (higher than the cutoff of 1.1) Despite intensive treatment, the infection progressed, leading to the patient undergoing right below knee amputation 43 days after SPECT/CT. (Bottom) Mild focal abnormal leukocyte accumulation was detected in the right 3rd and 4th toes. The lesions were in contact with the bone, which raised a suspicion of osteomyelitis (left panel, MIP image; right panel, axial SPECT/CT). A circular VOI was drawn on DFIs and the SUVmax was 1.0 (lower than the cutoff of 1.1). After 10 weeks of antibiotic treatment, the infection was successfully resolved, and the foot was preserved. Image and caption courtesy of Scientific Reports.

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Examples in two patients. (Top) Abnormal leukocyte accumulation was observed in the right 1st to 5th toes, with the radioactive lesions extending to the bone, indicating osteomyelitis (left panel, MIP image; right panel, axial SPECT/CT). Two spherical VOIs were drawn on diabetic foot infections (DFIs) and the highest SUVmax was 4.2 (higher than the cutoff of 1.1) Despite intensive treatment, the infection progressed, leading to the patient undergoing right below knee amputation 43 days after SPECT/CT. (Bottom) Mild focal abnormal leukocyte accumulation was detected in the right 3rd and 4th toes. The lesions were in contact with the bone, which raised a suspicion of osteomyelitis (left panel, MIP image; right panel, axial SPECT/CT). A circular VOI was drawn on DFIs and the SUVmax was 1.0 (lower than the cutoff of 1.1). After 10 weeks of antibiotic treatment, the infection was successfully resolved, and the foot was preserved. Image and caption courtesy of Scientific Reports.

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