Devices

Orthofix 3D Spinal Implant Cleared

FDA has cleared an Orthofix Medical 510(k) for its 3D-printed Construx Mini Ti Spacer System for use in enhancing anterior cervical discectomy and fusion (ACDF) procedures. ACDF procedures, which are often used to treat a herniated cervical disc or degenerative disc disease, involve replacing a patient’s damaged cervical disc with an interbody packed with a biologic to promote fusion in order to provide stability and strength to the area, according to the company. The device’s porosity and surface allows bone to grow into and through the spacer in order to aid with the patient’s fusion, it says.

“When compared to solid PEEK devices, the 3D-printed endplates of these implants with Nanovate Technology show a significant increase in growth factors involved in osteogenesis and osteoblast maturation resulting in a more favorable osteogenic environment for bone ingrowth,” Orthofix says. The device features a nanoscale surface that has been shown to increase proliferation and alkaline phosphatase activity and a“ functional gradient porous structure with 80% porosity at the midline of the implant which allows for increased fluoroscopic visualization.”

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