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GE HealthCare Gets FDA Approval of Flyrcado to Diagnose Coronary Heart Disease

By Stephen Nakrosis

 

GE HealthCare has received approval for Flyrcado, its enhanced diagnosis tool for coronary heart disease, from the Food and Drug Administration.

The company said on Friday that Flyrcado, or flurpiridaz F 18, injection is a radiotracer that assists in the diagnosis of the disease.

Since it can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, Flyrcado it has the potential to expand clinician and patient access to PET MPI, GE HealthCare said.

Flyrcado has a half-life of 109-minutes, which is longer than existing PET MPI tracers, and can enable combining exercise stress testing with cardiac PET imaging for CAD, according to the company.

Flyrcado will be available in initial U.S. markets early next year.

 

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

 

(END) Dow Jones Newswires

September 27, 2024 17:13 ET (21:13 GMT)

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