Devices

Boston Imaging V7 Ultrasound Cleared

FDA has cleared a Boston Imaging 510(k) for its V7, an ultrasound system designed for use with the company’s Crystal Architecture to enhance image clarity. The V7 is also equipped with “Intelligent Assist” features to be used in both general imaging and women’s health ultrasound cases. Boston Imaging says these include:

2D Follicle: An automated measurement tool that provides information about the status of follicles during gynecology examinations
AutoIMT: A screening tool to analyze a patient’s potential risk for cardiovascular disease.
S-Shearwave Imaging: A tool that provides quantitative non-invasive assessment and documentation of tissue stiffness for clinical applications including breast and liver.
UterineAssist: An artificial intelligence technology that automatically measures the size and shape of the uterus, assisting in detecting signs of uterine-related abnormalities.
E-Cervix: An elastography technology that provides an efficient semi-quantitative assessment of cervical canal stiffness.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome