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FDA expands Myoview label
Amersham Health has won FDA approval to market its Myoview radiopharmaceutical for the assessment of left ventricular function, specifically the calculation of LV ejection fraction and wall motion, in patients being evaluated for heart disease. The
Amersham Health has won FDA approval to market its Myoview radiopharmaceutical for the assessment of left ventricular function, specifically the calculation of LV ejection fraction and wall motion, in patients being evaluated for heart disease. The company's second largest selling product was first FDA approved and introduced in the U.S. in 1996 for cardiac perfusion studies. The additional indication is the latest example of Amersham's corporate strategy to expand the clinical utility of current products (SCAN 4/17/02).
In 2001, the FDA expanded Myoview labeling to include its use with pharmacologic stress agents in patients with known or suspected coronary artery disease. Last year, European authorities approved its use for imaging breast cancer. The product currently accounts for about 40% of the technetium cardiac market and more than 30% of the global myocardial perfusion market, according to Amersham.
European Society of Breast Imaging Issues Updated Breast Cancer Screening Recommendations
April 24th 2024One of the recommendations from the European Society of Breast Imaging (EUSOBI) is annual breast MRI exams starting at 25 years of age for women deemed to be at high risk for breast cancer.
Study Reveals Benefits of Photon-Counting CT for Assessing Acute Pulmonary Embolism
April 23rd 2024In comparison to energy-integrating detector CT for the workup of suspected acute pulmonary embolism, the use of photon-counting detector CT reduced radiation dosing by 48 percent, according to newly published research.
