Devices

Nyxoah’s Genio Device OK’d for Sleep Apnea

FDA has approved Nyxoah’s Genio system, a hypoglossal nerve stimulation (HGNS) therapy for certain patients with moderate to severe obstructive sleep apnea. The device is intended for adults with an Apnea-Hypopnea Index (AHI) between 15 and 65 events per hour.

The company says Genio offers HGNS treatment by delivering bilateral nerve stimulation and eliminating the need for an implanted battery. Instead, the system uses an MRI-compatible, leadless implant powered and controlled by an external, wearable component. The wearable can be upgraded over time, allowing patients to access technology updates without additional surgeries, it says.

The approval is based on data from Nyxoah’s DREAM pivotal trial, which met both its primary and secondary endpoints. Among participants, 63.5% met the study’s AHI responder criteria, and 71.3% met the Oxygen Desaturation Index responder criteria, it says. Patients with the device had their median AHI drop by 70.8%, with 82% of patients reducing their scores below 15.

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