Devices

FDA OKs Medtronic Pediatric Dialysis Device

FDA has granted marketing authorization for the Medtronic Carpediem system of continuous renal replacement therapy (CRRT) for use in pediatric patients with certain kidney conditions. An agency statement says that CRRT involves using a dialysis machine and a special filter to continuously clean a patient’s blood for an extended period, without stopping, instead of the more traditional three times a week therapy session. It is typically performed in intensive care units.

The statement says the Carpediem system is the first CRRT device intended for a lower weight-specific pediatric patient population who have a sudden or temporary loss of kidney function (acute kidney injury) or have too much water in their bodies because their kidneys are not functioning properly (fluid overload).

As part of the marketing authorization, FDA says, Medtronic will maintain a post-approval study to document real-world treatments in the U.S. The study will gather data on patient survival rates after discontinuing CRRT and timing of discharge from intensive care so the company can update labeling as needed to help ensure safe and effective use of the system by the wider pediatric nephrologist community.

FDA reviewed the Carpediem system through the de novo premarket review pathway.

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