Devices

Intera Oncology Recalls Hepatic Artery Pump

Intera Oncology has recalled its Intera 3000 Hepatic Artery Infusion Pump after receiving three reports that the pumps were delivering medications (flow rate) faster than expected. “If the pump delivers infusions at faster than expected flow rates, the patient may receive too much medication at one time, resulting in life-threatening hematologic (myelosuppression) toxicity, neurotoxicity, or death,” a recall notice says. “Additionally, if the flow rate is too fast, the patient may run out of medication before a pump refill occurs, which may allow their disease to progress or lead to death.”

The pump is used to continuously deliver medicine through an artery that supplies blood and oxygen to the liver and several other organs (hepatic artery). It is implanted into adult patients and delivers chemotherapy medications to treat liver tumors.

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