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news.The FDA has granted a standard review to Point Biomedical's new drug applicacation for Cardiosphere, an agent to be used in the diagnosis of obstructive coronary artery disease.
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Cardiosphere, a myocardial perfusion agent, is used with ultrasound imaging for the detection and localization of obstructive coronary artery disease. If approved for marketing, the company says that the agent will allow cardiologists to diagnose coronary artery disease in the office or hospital using standard ultrasound equipment and without the need for radioactive isotopes.
“We are extremely pleased that the FDA has accepted and is currently reviewing our NDA,” said Point CEO Dr Jerry Griffin. “We believe that Cardiosphere may offer important advantages to patients, physicians and payers.”
According to the company, over 10 million non-invasive imaging procedures were performed to diagnose coronary artery disease in the US last year.