Devices

Intuitive’s da Vinci SP Cleared for Otolaryngology

FDA has cleared an Intuitive 510(k) for the da Vinci SP robotic surgical system for use in certain transoral otolaryngology procedures in adults. FDA cleared the single port approach for lateral oropharyngectomy procedures (also referred to as radical tonsillectomy) and tongue base resection.

The device includes three, multi-jointed, wristed instruments and a fully wristed 3D HD camera. The instruments and the camera all emerge through a single cannula and are properly triangulated around the target anatomy at the distal tip to avoid external instrument collisions that can occur in narrow surgical workspaces, the company says. The system enables flexible port placement and varying internal and external range of motion (e.g., 360 degrees of anatomical access) through its single arm. Surgeons can control the articulating instruments and the camera on the da Vinci SP system, which uses the same surgeon console as the da Vinci X and Xi systems, Intuitive says.

Transoral otolaryngology procedures is the second procedural category for the da Vinci SP surgical system. In 2018, it was cleared for urology procedures.

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