Angiodynamics Inc., of Latham, N.Y., said the U.S. FDA approved the company's investigational device exemption (IDE) application for its DIRECT study with Nanoknife. The study will evaluate the system in the treatment of stage III pancreatic cancer.

The Zika virus caused great concern in 2016, with federal agencies turning to diagnostic companies for help in tackling the problem. Although the Centers for Disease Control and Prevention (CDC) said there were no cases of transmission by mosquitoes in the continental U.S. in 2018 and thus far this year, new research found that half a billion more people could be at risk for contracting mosquito-borne diseases, including Zika, in the next 30 years as a result of climate change. To help combat this problem, researchers from the Cary Institute of Ecosystem Studies and IBM Research have used machine learning to predict and identify areas in the Americas where populations could face a higher risk of contracting the Zika virus.

Marietta, Ga.-based Mirus LLC received the green light from the U.S. FDA for the MoRe-based Europa pedicle screw system. MoRe is a proprietary molybdenum rhenium superalloy for medical implants, and the company said this is the first medical device with this new class of implant material. The company is looking to help those undergoing spine deformity surgery, which said Munish Gupta, Mildred B. Simon distinguished professor of orthopedic surgery, director of adult/pediatric spinal deformity service and professor of neurological surgery at Washington University, is plagued with problems, including rod failure in 18 percent to 20 percent of adult patients.

Johnson & Johnson (J&J) Vision Inc. said patients wearing its investigational antihistamine-releasing contact lens (etafilcon A/0.019 mg ketotifen) had lower mean itching scores after their eyes were exposed to allergens vs. those wearing non-medicated control lenses, according to results from two phase III studies.

Warsaw, Ind.-based Zimmer Biomet Holdings Inc. won clearance from the U.S. FDA for its Rosa One spine system for robotically assisted minimally invasive and complex spine surgeries. "The clearance is meaningful as it further rounds out [Zimmer Biomet's] portfolio ahead of its full commercial launch in [the second half of 2019]," wrote Wells Fargo's Larry Biegelsen. He added that this latest application could serve as a big boost for the company, potentially contributing up to $15 million this year.

Novocure has kicked off the INNOVATE-3 pivotal trial evaluating the efficacy of tumor treating fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer. It marks the beginning of the company's fourth phase III pivotal trial to study solid tumors beyond glioblastoma.