Devices

Nyxoah Breakthrough Status for Apnea Device

FDA has granted Nyxoah a breakthrough device designation for its Genio bilateral hypoglossal nerve stimulation system and its use in treating patients with moderate to severe obstructive sleep apnea and complete concentric collapse of the soft palate. The designation is based on data from the company’s BETTER SLEEP trial. Recent top-line results showed that primary safety and performance endpoints were met, with statistically significant mean reduction in the Apnea-Hypopnea Index score in full patient population including complete concentric collapse patients, according to the company. The full study data will be submitted to a medical journal for upcoming publication, it says.

Nyxoah says it is currently conducting the DREAM IDE pivotal study to support PMA submission. The device received a European CE Mark in 2019.

The company describes Genio as a battery-free, leadless neurostimulator that was designed to bilaterally stimulate the hypoglossal nerve, which maintains the upper airway. It is implanted under the chin and placed over the genioglossus muscle, close to the tongue’s hypoglossal nerve. Stimulating the nerve triggers a slight forward movement of the tongue’s posterior, which helps to maintain an open airway, Nyxoah 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