Devices

Millennium Dental Gains Clearance for Periodontal Regeneration

FDA has cleared a Millennium Dental Technologies 510(k) for periodontal regeneration (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface using the company’s LANAP protocol. Using a PerioLase MVP-7 laser, doctors can “stimulate and activate oral stem cells, in particular fibroblasts, to form the necessary cellular components that turn into regenerated tissue,” the company says. “This 1064nm laser wavelength passes through healthy tissue and is selectively absorbed in bacteria and diseased tissues without harming other tissues.”

Millennium says the laser energy penetrates 4-6mm beyond the tissue surface to kill bacteria and eliminate infection and inflammation. “Once the mouth has been cleared of infectious agents, the laser interacts with hemoglobin to seal the gums with stable fibrin clotting, to achieve a clean, closed environment to create true regeneration,” it says. “Multiple peer-reviewed, post procedure studies tracking results over time, show increased regeneration and continued improvement of oral health.”

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