FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved the use of Animas Corp.’s Vibe Insulin Pump and Continuous Glucose Monitoring (CGM) System for managing diabetes in children and adolescents, ages two to 17. The company says the system allows patients and their caregivers to view glucose data and administer insulin right from the pump, making it easy to fine-tune insulin delivery to help manage their diabetes.

Bio2 Technologies, Inc. has received FDA 510(k) clearance for its Fusion Implant system for interphalangeal fusion, fracture repair and osteotomies of the toes, fingers and other small bones in the presence of appropriate immobilization.

FDA has granted approval of a new indication for Integra LifeSciences’ Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers that last for longer than six weeks and do not involve exposure of the joint capsule, tendon or bone, when used in conjunction with standard diabetic ulcer care. The device, originally approved in 1996 for treating life threatening burn injuries, is made of silicone, cow collagen, and shark cartilage and is placed over the ulcer to provide an environment for new skin and tissue to regenerate and heal the wound, according to an FDA news release.

MST-Medical Surgery Technologies has received FDA clearance for its Follow Me software designed for minimally invasive robotic surgery.

DRUGS

FDA has granted Vtesse, Inc.’s VTS-270 breakthrough therapy designation status for treating Niemann-Pick Type C1 Disease.

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