Devices

Petition Seeks Removal of Bamboo’s NarxCare Software

The Center for U.S. Policy (CUSP) has filed a Citizen Petition asking FDA to deem a widely used clinical decision support software, Bamboo Health’s NarxCare, a misbranded medical device and to mandate a recall to prevent serious, adverse health consequences and death.

The software is a substance use disorder (SUD) analytics tool that produces a risk score using data from state prescription drug monitoring programs (PDMPs) and other sources. “PDMPs are used by administrative and law enforcement agencies to surveil health care practitioners’ prescribing, pharmacists’ dispensing, and patients’ receipt of controlled medications,” CUSP says. It further contends that the score produced by the software influences prescribers’ opioid, sedative, and stimulant prescribing decisions by calculating and reporting the likelihood that a patient will misuse substances, develop an SUD, or experience drug poisoning.

The petition says FDA has not substantiated the safety and effectiveness of the device, and it urges the agency to issue a Warning Letter to the manufacturer, order a recall, and take any other actions to prevent “adverse health consequences or death.”

Read the full petition here.

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