Devices

Zeiss Medical Gets Clearance for Intrabeam 700

FDA has cleared a Zeiss Medical Technology 510(k) for its Intrabeam 700, a robotic-assisted platform to support intraoperative radiation therapy for use in neurooncology and breast cancer therapy.

In oncological treatments, the device ensures that the target area is optimally resected, and that healthy tissue is spared as much as possible, according to the company. Particularly in contact irradiation, it says the target focus always remains the same throughout the entire treatment, without interruptions or unintended movements. “Once the applicator is in place, the active damping and the stand dynamics reduce residual vibrations to a minimum,” it adds.

Zeiss says the device can be integrated “seamlessly into the surgical infrastructure and the hospital information system. Direct access to leading digital solutions from Zeiss enables faster routine workflows and simplified data management. The platform also provides integrated applicator recognition and confirmation through embedded radio frequency identification (RFID) technology.”

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