Hoffman Estates, Ill., April 10, 2012 — Siemens Healthcare is the first company worldwide to announce a complete integrated diagnostic imaging solution proposed for the detection of amyloid plaques — one of the necessary pathological features of Alzheimer’s disease1,2,3 — in the living brain. The latest elements of Siemens’ integrated solution came today with the company’s U.S. Food and Drug Administration (FDA) 510(k) application for its syngo®.PET Amyloid Plaque4 proprietary neurology quantification software, as well as the recent FDA approval of Eli Lilly and Company’s Amyvid™ (Florbetapir F 18 Injection), a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.5
Siemens integrated amyloid imaging solution encompasses three unique elements — the new Biograph mCT™ PET•CT scanner, FDA 510(k)-pending syngo.PET Amyloid Plaque neurology quantification software and the manufacturing and distribution of Amyvid. All are examples of Siemens Healthcare’s innovative power and competitiveness, which are two goals of the company’s global initiative, Agenda 2013.
As the largest producer and distributor of Amyvid, PETNET Solutions, Siemens’ network of PET drug manufacturing establishments, will begin supplying Amyvid to imaging centers in limited U.S. markets beginning in June 2012. Complementing the new radioactive diagnostic agent, Siemens pending software could potentially support the quantification of amyloid plaque in the brain. Combined with the company’s family of high-resolution PET imaging scanners, Siemens now announces for the first time an integrated diagnostic tool for patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.