The FDA expanded the uses of GE HealthCare’s Vizamyl imaging agent for highlighting the presence of beta amyloid proteins in the brain, with new green lights that enable more objective scans and the ability to track the benefits of new therapies.
Vizamyl (flutemetamol F-18) was first approved by the agency in 2013. The radioactive injection has been used during PET brain scans to help providers visually interpret the extent of plaque buildups that have been linked to cognitive decline, alongside other diagnostic tools—itself a largely subjective process.
Now, the imaging agent can be used to deliver quantitative assessments—such as calculations of amyloid prevalence through FDA-authorized software—which GE HealthCare said will offer more objective and consistent readings among clinicians.
At the same time, the FDA lifted a previous restriction on using Vizamyl to illustrate a patient’s response to anti-amyloid therapies, allowing providers to potentially know when to stop treatment.
“The inclusion of quantification and removal of the therapy monitoring limitation from the Vizamyl label is good news for healthcare providers and their patients, further enabling timely and appropriate care decisions,” Jit Saini, M.D., chief medical officer of GE HealthCare’s pharmaceutical diagnostics division, said in a statement.
“These changes pave the way for clinicians to expand their usage of Vizamyl, with meaningful implications for patients and their families—helping provide clearer answers, earlier diagnoses, and enabling more personalized treatment strategies,” Saini said.
The updates to Vizamyl’s indications also nixed a previous limitation on predicting declines or progression to dementia from the early phases of mild cognitive impairment and now allow for the agent’s use in diagnosing Alzheimer’s based on an abnormal amyloid PET scan.
Last September, GE HealthCare picked up an FDA clearance for a software tool to quantify the density of amyloid plaques in the brain.
The MIMneuro program reads PET images and delivers a score of 0 to 100, with the latter representing the typical patient with Alzheimer’s. The program was developed by the company’s MIM Software division, which it acquired in April 2024 through a $295 million cash deal.
Last year, the company also collected an FDA approval for another F-18 radiotracer, Flyrcado (flurpiridaz), for coronary artery disease and assessing the perfusion of heart muscle cells. Earlier this week, GE HealthCare said Flyrcado is now covered by all seven Medicare administrative contractors as well as more than half of the nation’s commercially insured population.