Devices

Surgical Planning’s New HipInsight Cleared

FDA has cleared a Surgical Planning Associates 510(k) for its new HipInsight 2.0 mixed-reality guidance system for hip arthroplasty. The device is updated with “enhanced features to support the essential steps of both primary and complex revision arthroplasty,” the company says, adding that it provides surgeons with X-ray insight to see detailed sequential three-dimensional information in and around a patient’s hip joint.

Surgical Planning Associates says the device now enables a newly patented method of “overlaying the powerful digital content onto the patient making workflow more wide-ranging, seamless, and applicable to any surgical technique. Traditionally, surgeons must perform a three-dimensional procedure based on two-dimensional X-ray planning and often intraoperative X-ray assessment. The HipInsight system puts three-dimensional information onto mixed-reality display eyeglass lenses so surgeons have more intuitive knowledge and don't have to take their eyes off of the patient.”

For those surgeons not choosing to use X-rays in surgery, the device can also generate “future X-rays” in advance that show the desired surgical result, the company says. “These future X-rays can be displayed on the mixed-reality device to project onto actual intraoperative X-rays so that the surgeon can see a live comparison during surgery,” it adds.

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