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.
FDA Clears Ultrasound AI Detection for Pleural Effusion and Consolidation
June 18th 2025The 14th FDA-cleared AI software embedded in the Exo Iris ultrasound device reportedly enables automated detection of key pulmonary findings that may facilitate detection of pneumonia and tuberculosis in seconds.
Can Contrast-Enhanced Mammography be a Viable Screening Alternative to Breast MRI?
June 17th 2025While the addition of contrast-enhanced mammography (CEM) to digital breast tomosynthesis (DBT) led to over a 13 percent increase in false positive cases, researchers also noted over double the cancer yield per 1,000 women in comparison to DBT alone.
Ultrasound-Guided Thermal Ablation Shows Low Recurrence of Thyroid Carcinoma at Five Years
June 16th 2025In a meta-analysis involving over 2,200 patients with T1NoMo papillary thyroid carcinoma, researchers noted 2 percent recurrence and no cases of lymph node metastasis five years after ultrasound-guided thermal ablation.