Devices

FDA OKs 1st At-Home Stimulator for Depression

FDA has approved the first at-home, prescription-only brain-stimulation device to treat major depressive disorder. Flow Neuroscience says its FL-100 system, a transcranial direct current stimulation (tDCS) device, is designed for adults with moderate to severe depression. It is intended as a stand-alone intervention or as an adjunct to existing treatments such as medication or psychotherapy.

tDCS delivers low-intensity electrical currents to the prefrontal cortex, a brain region involved in mood regulation and stress response, the company says. Flow’s headset pairs with a mobile app and applies stimulation in structured sessions under clinician oversight.

Clinical trial data were recently published in Nature Medicine, demonstrating symptom improvement beginning as early as three weeks. According to the company, the trial—described as the largest fully remote neuromodulation study for depression—showed:

Active tDCS significantly outperformed sham stimulation.
Two- to three-fold higher remission and response rates compared with placebo.
58% of participants in remission after 10 weeks of treatment.

Flow also reported strong real-world outcomes from more than 55,000 users in Europe, with 77% seeing symptom improvement within three weeks. Adverse events observed with FL-100 are typically mild and temporary, including skin redness, irritation, dryness, or a transient headache. Stinging or itching under the electrodes is common, it says, adding that skin burns may occur if electrode pads are reused or applied when dry.

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