Devices

Medtronic PillCam At-Home Endoscopy

FDA has granted Medtronic 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures. The device provides a telehealth option for direct visualization and monitoring of the small bowel to help detect lesions not detected by upper and lower endoscopy that may signal Crohn’s disease, obscure bleeding, or iron deficiency anemia, according to the company. Through a telehealth appointment, a healthcare provider guides the patient through the remote procedure, which includes swallowing a camera capsule, and the patient returns the data recorder and sensor belt to Medtronic once the procedure is complete.

Medtronic says PillCam is designed to deliver images of the mucosa and offers adaptive frame rate technology to support image acquisition as well as the tools needed to record them for a clinician to interpret. During the eight-hour procedure, the device capsule transmits about 50,000 images, it says, adding the the images are securely transferred to the cloud.

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