Neusoft taps TUV for FDA help

AuntMinnie.com staff writers

Oct 22, 2007

Neusoft Positron Medical Systems of Shenyang, China, is partnering with global regulatory compliance firm TUV of Newtown, CT, for help with a FDA 510(k) submission for Neusoft's Attrius PET camera.

Neusoft Medical Systems is a joint venture partner with PET developer Positron of Houston.

By AuntMinnie.com staff writers
October 23, 2007

Related Reading

Positron opens Chinese joint venture, February 13, 2006

Positron, Neusoft enter joint venture, August 30, 2005

Positron launches cardiac PET, October 17, 2007

Positron gets solid-state patents, March 5, 2007

Positron partners with MIMvista, September 7, 2006

Copyright © 2007 AuntMinnie.com

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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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