Devices

FDA Clears SpineGuard Pedicle Screw Placement System

FDA has cleared a SpineGuard 510(k) for the PediGuard Threaded DSG device for use in pedicle screw insertion. “A single-use DSG pin embedded with the bipolar sensor is inserted into the cannula of the threaded shaft and connected to the electronic processor inside the single-use DSG handle.” the company says. “The distal tip of the threaded shaft includes an awl-like tip to facilitate redirection of the device until the tip is past the pedicle isthmus.”

The company says PediGuard is the first stand-alone, handheld instrument capable of accurately detecting changes in tissue type, alerting surgeons of potential pedicular or vertebral breaches during pedicle screw site preparation. Real-time feedback, provided via audio and visual signals, gives surgeons additional information about the trajectory during pedicle preparation.

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