Devices

FDA Clears Medtronic Reveal LINQ Cardiac Monitor

FDA has cleared a Medtronic 510(k) for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection, an advanced cardiac monitor offering designed to identify abnormal heartbeats. The device offers “exclusive algorithms that result in a 95% reduction in false bradycardia (slow heartbeat) episodes and a 47% reduction in false pause (brief absence of cardiac activity) episodes when compared with its predecessor, the Reveal LINQ ICM,” the company says. The device also features a self-learning atrial fibrillation (AF) algorithm, which learns and adapts to a patient's heart rhythm over time. “AF episodes, which are most likely to trigger false positives with ICMs, experienced a 49% reduction in false detections with the Reveal LINQ ICM with TruRhythm Detection when compared to the Reveal LINQ ICM,” Medtronic 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