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New Products In Brief

FDA clears skin-cancer companion diagnostic. Medtronic announces two AAA-related approvals. OrbusNeich launches dual-therapy stent outside the U.S. More new products.

FDA has approved BioMerieux Inc.’s THxID BRAF kit, a companion diagnostic test that will help determine if a patient’s melanoma cells have BRAF V600E or V600K gene mutations. The diagnostic was approved May 29 along with GlaxoSmithKline Inc.’s Tafinlar and Mekinist drugs for patients with advanced or unresectable melanoma, the most serious type of skin cancer. Approximately half of melanomas arising in the skin have a BRAF gene mutation, FDA says. FDA’s approval of the THxiD BRAF test is based on data from clinical studies that support the Tafinlar and Mekinist approvals. Samples of patients’ melanoma tissue were collected to test for the mutation.

Aptus Endosystems Inc. announced 510(k) clearance May 28 for its 28mm Tip Reach Heli-FX guide, a line extension of the original Heli-FX system, for treatment of wide-neck abdominal aortic aneurysms....

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