Devices

X-trodes’ Wearable Electrophysiological Monitor Cleared

FDA has cleared an X-trodes 510(k) for its X-trodes Smart Skin device, a wireless wearable technology for electrophysiological monitoring. The device comprises customizable dry-printed multi-modal electrode patches that are intended to monitor a range of biopotential signals from anywhere on the body to acquire EEG (brain activity), EKG/ECG (cardiac monitoring), EOG (eye movement), and EMG (muscle activity) data, according to the company. The patches conform to the body without requiring gels, wires or “uncomfortable solutions,” it says.

The clearance is based on an “extensive scientific assessment” that showed the performance of the X-trodes technology to be equivalent to that of FDA-cleared clinical electrophysiology devices in measuring EEG, EOG, EMG, and EKG/ECG signals, the company says. “Having achieved FDA 510(k) clearance, X-trodes will pursue further validations for a wide range of clinical use cases, with an initial focus on the cardiovascular and sleep monitoring markets,” it adds.

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

Read more

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