Drugs

Product Approval Summaries

DEVICES

FDA has cleared a Cynosure 510(k) for the SculpSure, a hyperthermic laser treatment for lipolysis of the flanks. The device works by disrupting subcutaneous fat cells. The hands-free device features a flexible applicator system to treat multiple anatomical areas of the body, according to the company. SculpSure, which uses a 1060 nm laser, can treat an anatomical area in about 25 minutes.

FDA has cleared a Nitiloop 510(k) for its NovaCross, which is intended to be used in conjunction with a guidewire to access discrete regions of the coronary or peripheral vasculature. The device functions both as a competent supporting microcatheter and as a premium low-profile microcatheter on its own, according to the company. Its support use comes from the operator-controlled Nitinol scaffold and an extendable segment, both located at its distal end.

Visage Imaging Inc. has received FDA 510(k) clearance for the use the Visage Ease Pro for mobile diagnostic interpretation of all imaging modalities except mammography.

HUMAN DRUGS

FDA has approved a Janssen Pharmaceuticals NDA for Invega Trinza (paliperidone palmitate), a three-month long-acting atypical antipsychotic indicated to treat schizophrenia. Before starting Invega Trinza, patients must be adequately treated with Invega Sustenna (one-month paliperidone palmitate) for at least four months. The submission received a priority review.

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