Devices

MediView Surgical Augmented Reality Device Cleared

FDA has cleared a MediView XR 510(k) for its XR90 augmented reality (AR)-based surgical visualization and navigation platform. XR90 is intended to be used in ultrasound and CT guided needle-based procedures involving soft tissue and bone, the company says. “XR90’s augmented reality capabilities include a holographic light ray that tracks and displays the path of the physician’s instrument, CT-based 3D holographic anatomy display, and live ultrasound that is projected and displayed anatomically into the patient as the clinician scans, similar to a flashlight beam.”

Mediview says the device was designed to address long-standing limitations of current medical imaging technologies, such as flat panel monitors that limit practitioners to 2D imaging and require them to look away from a patient’s procedural site, “disrupting hand-eye-coordination, resulting in reduced clinician confidence and potentially impacting outcomes.”

XR90 uses Microsoft’s Hololens2 AR headset to permit clinicians to visualize a patient’s ultrasound, as well as displays of other procedural information to enhance their workflow, MediView says. The display allows physicians to “visualize a patient’s comprehensive internal anatomy in 3D underneath their skin, including bone, tissue, organs and vasculature,” it adds. “The device projects 3D virtual models of the patient’s own anatomy based on their CT imaging and combines that CT with live ultrasound to perform minimally invasive procedures, such as biopsies and tumor ablations (the use of heat or cold to kill cancerous tumors).”

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