Viveve has started a trial of its cryogen-cooled monopolar radiofrequency technology intended for treatment of stress urinary incontinence in women. The study, which will include up to 10 sites across Canada, will randomize 100 patients using a 2-to-1 ratio for experimental or sham treatment.
Thirty-one of 45 children's breakfast foods and cereals, such as granolas, oats and snack bars, had levels of glyphosate, a weed-killing chemical associated with cancer, exceeding what some consider to be safe levels for children, an Environmental Working Group report found. The report also showed that only two products didn't contain glyphosate.
Preliminary CDC data showed US drug overdose mortality hit record levels last year, increasing to more than 72,000 deaths, driven mainly by the continued increase in fatalities involving fentanyl and other synthetic opioids. Overdose deaths from synthetic opioids rose by more than 9,000 from the prior year, reaching almost 30,000 deaths in 2017, while fatalities from heroin, prescription opioids and methadone have dropped.
Two EHR-integrated, web-based tools that use Substitutable Medical Applications and Reusable Technologies on the Fast Healthcare Interoperability Resources standard are being launched by Geisinger Health System and Merck. The Family Caregiver app is designed to support communication between health care providers and caregivers, while the MedTrue app is meant to improve medication adherence and reconciliation by integrating medication data with clinical workflows.
Vertex Pharmaceuticals' Kalydeco, or ivacaftor, was approved by the FDA for pediatric patients age 12 months to younger than 2 years old with cystic fibrosis who have at least one mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive to the drug based on clinical and/or in vitro test data. The decision was backed by data from a late-stage trial, in which the drug showed a consistent safety profile to that seen in prior late-stage studies of older children and adults with CF.
Onspira Therapeutics' OSP-101, being developed as a treatment for post-lung transplant patients with bronchiolitis obliterans, received orphan drug designation from the FDA.
Health officials in the US are proposing to do away with special regulations pertaining to gene therapy experiments, and revisions will be implemented upon completion of a public comment period, NIH Director Francis Collins and FDA Commissioner Scott Gottlieb write in The New England Journal of Medicine. However, as more gene therapies are developed using gene-editing technology, "this is not the right time to be making any moves based on the idea that we know what the risks are," says Mildred Cho of the Stanford Center for Biomedical Ethics.
Invuity has announced the launch of its PhotonGuide Adapt system, which comes with retractors and a flexible illuminator for facilitating vaginal surgical procedures, such as vaginal hysterectomies and pelvic organ prolapse repairs. The system's waveguide, intended to conform to various retractor sizes and shapes, enables adjustment of illumination along the retractor's length.
China FDA granted priority review status to Correvio Pharma's Brinavess, or vernakalant hydrochloride, IV, indicated for the rapid conversion of recent onset atrial fibrillation. A late-stage trial assessed the drug in AF patients from Korea, Hong Kong, Taiwan and India, and is anticipated to show no difference in Brinavess' efficacy or safety across ethnicities.