Devices

Apollo TMS Cleared for Depressed Adolescents

FDA has cleared a new indication for neurocare group AG’s Apollo TMS (transcranial magnetic stimulation) therapy device to treat adolescents with major depressive disorder. A company statement says there are currently only two oral antidepressants approved for this age group, and both have Boxed Warnings for an increased risk of suicidal ideation and action. It says the drugs have a 35% effectiveness rate in achieving remission, and many patients discontinue them due to side effects or a lack of clinical benefit.

“TMS offers a safe, non-invasive, and drug-free alternative, with no Boxed Warning and no medication-related side effects,” the statement says. Clinical studies show that approximately 60% of patients achieve remission with TMS, making it a promising new treatment option for adolescents who have not found success with other treatments, according to neurocare.

The company says the Apollo TMS product line is already FDA cleared to treat major depressive disorder in adult patients who have not had an adequate response to oral antidepressants. It has also been cleared by FDA as an adjunctive treatment for obsessive-compulsive disorder in adults who have not responded to traditional therapies.

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