Devices

FDA OKs Medtronics Next-Gen SynchroMed

FDA has approved Medtronic’s next-generation SynchroMed III intrathecal drug delivery system for patients with chronic pain, cancer pain, and severe spasticity. The device is described as a targeted drug delivery platform that alleviates symptoms by delivering medication directly to the fluid surrounding the spinal cord. “SynchroMed III is an upgraded system compared to the SynchroMed II system, featuring a new ‘refill only’ physician workflow for more efficient programming, improved electronics with firmware capable of being updated after implant, and additional protections for patient data through enhanced cybersecurity,” the company says.

Medtronic says the new system can be used with its Control Workflow, which is designed to help eliminate the use of systemic opioids by certain patients. “Control Workflow is a framework that can be tailored to individual patients and assists physicians in identifying patients likely to have positive outcomes,” it says. “It supports oral opioid tapering and drug holidays, allowing for treatment with the lowest effective dose of intrathecal medication, which may improve pain relief compared to a combination of oral and intrathecal treatment.”

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