Devices

eCential Robotics Bone Surgical System Cleared

FDA has cleared an eCential Robotics 510(k) for its 3D imaging, navigation and robotics guidance system for use in bone surgical procedures. The device features a single user interface to control functions from a single input and output graphical display screen, according to the company. It is a fully “open solution,” which means it can be used with any manufacturer’s implants. “Built around a range of applications currently dedicated to spine surgery, the eCential Robotics platform will in the future expand to multiple bone surgery indications,” the company says.

eCential says the device comprises three mobile interconnected units: a mobile C-arm, a mobile viewing workstation, and a mobile collaborative robot. The mobile, five-axis X-ray imaging robot supports 2D imaging and 3D imaging of anatomical structures and high contrast objects, it says, adding that the navigation uses 3D optical position tracking technology and instruments equipped with marker spheres to enable an exact localization in space.

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