Devices

FDA Authorizes Click’s Migraine Digital Therapeutic

FDA has granted Click Therapeutics a de novo marketing authorization for its prescription digital therapeutic, CT-132, which it describes as the first prescription digital therapeutic for preventing episodic migraine. The company says it is intended for adjunctive use alongside acute or other preventive treatments for migraine. The device “delivers a proprietary 12-week clinical intervention aimed at reducing brain hypersensitivity implicated in migraine by modulating patient responses to environmental and internal stimuli to help restore patients' ability to engage fully in daily activities,” it says.

The marketing authorization is based on data from the ReMMi-D (Reduction in Monthly Migraine Days, NCT05853900) study in patients taking standard-of-care prescription migraine medications (acute, preventive first-line, and preventive second-line), according to the company. Data showed a statistically significant reduction in monthly migraine days (MMDs) following 12 weeks of treatment compared to sham, with the treatment arm experiencing -3.04 MMDs by end of treatment.

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