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FDA says AMI agent is approvable
MRI contrast developer Advanced Magnetics of Cambridge, MA, hasscored its second approvable letter this year from the Food andDrug Administration. AMI announced this month that the agencyhas indicated that its Gastromark agent for MRI of the
MRI contrast developer Advanced Magnetics of Cambridge, MA, hasscored its second approvable letter this year from the Food andDrug Administration. AMI announced this month that the agencyhas indicated that its Gastromark agent for MRI of the gastrointestinaltract is approvable. The FDA issued a similar letter earlier thisyear for AMI's Feridex IV agent (SCAN 2/14/96).
Final FDA approval of Gastromark will trigger a milestone paymentto AMI from Mallinckrodt Medical, which has rights to the productin the U.S., Canada, and Mexico. Guerbet of France markets theproduct in Western Europe as Lumirem.
In other AMI news, the company has decided to take advantage ofthe recent drop in its stock price by authorizing a plan to buyback 250,000 of its 6.8 million shares outstanding.
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.
Could a Newly FDA-Cleared C-Arm Device Bolster Efficiency for Interventional Radiologists?
April 22nd 2024In addition to advanced imaging quality and dose efficiency, the Philips Zenition 30 mobile C-arm device emphasizes personalized user profiles and automated customization to help reduce procedure time.
