Taiwan FDA has approved NeuraCeqTM(florbetaben F18 injection) for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. In June 2019, PET Pharm Biotech was approved for PIC/S GMP extension and got the medicine license of NeuraCeqTM(florbetaben F18 injection) and from Taiwan FDA.
https://www.fda.gov.tw/mlms/H0001D.aspx?Type=Lic&LicId=51R00036
Read MoreA first-of-its-kind national study has found that a form of brain imaging that detects Alzheimer’s-related “plaques” significantly influenced clinical management of patients with mild cognitive impairment and dementia.
The study revealed that providing clinicians with the results of positron emission tomography (PET) scans that identify amyloid plaques in the brain changed medical management — including the use of medications and counseling — in nearly two-thirds of cases, more than double what researchers predicted in advance of the study. The technique, known as “amyloid PET imaging,” also altered the diagnosis of the cause of cognitive impairment in more than one in three study participants.
https://www.ideas-study.org/2019/04/01/results-of-the-ideas-study-just-published-in-jama/
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