FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a K2M Group Holdings 510(k) for its Yukon Oct Spinal System, a device intended to facilitate fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine. The device features “newly designed top-loading, high angulation, polyaxial screws that provide up to 105 degrees of polyaxial angulation,” the company says. Its screw heads accept both 3.5 and 4.0 mm rods in both cobalt chrome and titanium, and accommodate construct rigidity based on degenerative or deformity corrections, it says.

FDA has cleared a Hologic 510(k) for the body laser contouring product SculpSure to treat a double chin (submental area). The device is also cleared to treat the abdomen, love handles, back, and inner and outer thighs. Clearance was based on data from a 57-person clinical trial where patients received two brief treatments six weeks apart. The treatment uses a laser to raise the temperature of body fat to disrupt and destroy fat cells under the skin. The fat cells are then naturally eliminated over time and do not return, the company says.

DRUGS

FDA has granted accelerated approval to Merck’s Keytruda (pembrolizumab) for treating patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. The expanded approval is intended for patients experiencing disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. Keytruda has been approved for 10 other indications, including melanoma, lung cancer, head and neck cancer and Hodgkin lymphoma.

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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