Drugs

Abbott Insertable Cardiac Monitor Cleared

FDA has cleared an Abbott 510(k) for its Assert-IQ insertable cardiac monitor (ICM) for diagnosing and long-term monitoring of people experiencing irregular heartbeats (arrhythmias). ICMs are small devices with sensors inserted just under the chest’s skin to provide constant, real-time monitoring of a person’s heart to detect and identify arrhythmias, the company says.

Assert-IQ is designed to offer two options with a battery life of at least three or six years, according to Abbott. “While the three-year option may be preferred for more traditional monitoring, such as diagnosing fainting, heart palpitations or detections of abnormal heart rhythms, an option offering at least six years of battery life empowers physicians to monitor long-term,” it says. “This monitoring can be especially important when caring for people who are undergoing therapy, have recently had a cardiac ablation procedure or who are at risk of developing further arrhythmias such as atrial fibrillation.”

The device also uses Bluetooth technology to remain connected to a patient’s cell phone to check heart rhythms every 20 seconds, and to transmit results in real-time to the clinic’s portal. Additionally, some models of ASSERT-IQ can be remotely programmed allowing the clinician to adjust the device’s settings to “optimize performance and limit unnecessary alerts or transmissions – all without requiring the patient to visit the clinic,” Abbott says.

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