Devices

FDA Clears 2 Siemens Digital Radiography Devices

FDA has cleared a Siemens Healthineers 510(k) for the Multix Impact C ceiling-mounted digital radiography (DR) system as well as the Multix Impact VA20, a new version of the established floor-mounted parent DR system. Both devices feature intuitive operating systems, versatile wireless detectors, motorized tube heads, and a free-floating, flat tabletop for easier patient access. “With the X-ray tube’s touch user interface, the radiologic technologist can remain by the patient’s side for longer periods,” the company says.

The devices also use the company’s “myExam companion” user interface to provide proactive guidance to help technologists of any skill level navigate a radiography procedure, Siemens says. “With myExam Companion’s camera-based Smart Virtual Ortho feature, the technologist can set the field of view and adjust exposure parameters on the touchscreen using a live camera image of the patient, so long-leg and full-spine examinations can be set up and performed more easily,” it says.

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