Devices

DirectSync Gets ‘Breakthrough’ on Spinal Fusion Device

FDA has granted DirectSync Surgical a breakthrough device designation for its patient-powered smart spinal fusion device. The designation is based on FDA’s review of preliminary data that determined the DirectSync Surgical interbody device may provide a more effective spinal fusion than the current standard of care, the company says. “The product delivers localized electrical stimulation and provides post-operative diagnostics to achieve fusion more effectively for patients indicated for spinal fusion,” it says.

The device is designed to provide “targeted mechanically synced electrical stimulation for enhanced bone healing and post-operative data collection to inform and optimize the treatment regimen between the physician and their patient,” DirectSync says.

“An all-in-one interbody fusion device that has a therapeutic aspect as well as a diagnostic tool to allow me to know when and if fusion is taking place has the potential to revolutionize my practice,” Carle Foundation Hospital neurosurgeon and DirectSync Surgical co-founder Paul Arnold is quoted in a release as saying.

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