The FDA approved Neuraceq for PET imaging of the brain to identify beta-amyloid neuritic plaque in patients with cognitive decline or Alzheimer’s disease.
The U.S. Food and Drug Administration (FDA) announced today its approval for Neuraceq, which is indicated for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in cognitively impaired adult patients being evaluated for Alzheimer’s disease or other cognitive decline.
There are over seven million new cases of dementia each year worldwide, with Alzheimer’s disease accounting for 60 percent to 80 percent of all dementia diagnoses. Studies have shown that Alzheimer’s gets incorrectly diagnosed in 10 percent to 30 percent of cases, leaving many patients without appropriate treatment.
The Centers for Medicare and Medicaid Services has stated it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development programs, which aim to assess the impact of beta-amyloid scans on improving patient outcomes or advancing treatment options. Beta-amyloid is the primary indicator of Alzheimer’s.
The FDA approval was based on safety data from 872 patients who participated in global clinical trials, and three studies that examined images from adults with a range of cognitive function. The studies included 205 end-of-life patients who had agreed to participate in a post-mortem brain donation program. Images were analyzed from 82 subjects with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and could be useful in estimating the density of these plaques in life.
Neuraceq is manufactured by Piramal Imaging, a division of Piramal Enterprises, Ltd.
CT Study: AI Algorithm Comparable to Radiologists in Differentiating Small Renal Masses
May 14th 2024An emerging deep learning algorithm had a lower AUC and sensitivity than urological radiologists for differentiating between small renal masses on computed tomography (CT) scans but had a 21 percent higher sensitivity rate than non-urological radiologists, according to new research.
The Reading Room: Racial and Ethnic Minorities, Cancer Screenings, and COVID-19
November 3rd 2020In this podcast episode, Dr. Shalom Kalnicki, from Montefiore and Albert Einstein College of Medicine, discusses the disparities minority patients face with cancer screenings and what can be done to increase access during the pandemic.
Study Finds High Concordance Between AI and Radiologists for Cervical Spine Fractures on CT
May 6th 2024Researchers found a 98.3 percent concordance between attending radiology reports and AI assessments for possible cervical spine fractures on CT, according to new research presented at the 2024 ARRS Annual Meeting.