Senseonics Holdings Inc., of Germantown, Md., scored a win with the FDA, which approved the company's Eversense continuous glucose monitoring (CGM) system for people with diabetes. The system features an implantable glucose sensor and provides long-term continuous monitoring for up to three months.
After a four-year wait, Monrovia, Calif.-based Staar Surgical Co. (NASDAQ:STAA) received a close-out letter from the FDA this week. This action lifts a warning letter dated May 21, 2014, that, among other issues, hit the company for failing to establish procedures for evaluating complaints. The company closed at $32.65 on Wednesday after closing $29.40 the previous day.
Beckman Coulter Diagnostics, of Brea, Calif., is highlighting results from a study showing that blood tests could offer hope during the initial screening of patients for obstructive sleep apnea (OSA). The study, which included 264 adult male patients, showed that screening for changes in three biomarkers – hemoglobin A1c (HbA1c), C-reactive protein (CRP) and erythropoietin (EPO) – may prove useful in identifying patients with the disorder.
Johnson & Johnson (J&J) Vision, which has headquarters in Jacksonville, Fla., and Santa Ana, Calif., won FDA approval for technology intended to personalize a Lasik procedure. The Idesign refractive studio uses topography-integrated, wavefront-guided technology to allow physicians to make measurements of the eye.
Wright Medical Group NV won FDA approval for its Augment injectable bone graft. As a result, the company plans to update its 2018 guidance on its second quarter earnings call.
Diabetes patients soon will have a new option in Europe after Dexcom Inc. received the CE mark for its G6 continuous glucose monitoring (CGM) system for patients 2 years of age and older. The Dexcom G6 CGM system will be available in the U.K. and Ireland by the end of June and in other European countries later this year.
Fremont, Calif.-based Optovue Inc. received 510(k) clearance for Angioanalytics, an optical coherence tomography angiography (OCTA) blood vessel measurement technology to help manage diseases that cause progressive blindness. In addition, the agency has given the green light to the company's three-dimensional projection artifact removal (3D PAR) software, which aims to boost OCTA image quality.
BOSTON – How will machine learning, precision medicine and artificial intelligence (AI) affect the future of treatments? That question helped frame a panel discussion at the BIO International Convention. Much of the discussion focused on data being collected. "We talk about real-world data, and this is a buzzword," said Scott Solomon, the Edward D. Frohlich distinguished chair, professor of medicine at Harvard Medical School. He added that most real-world data are not very good, and an effort must be made to improve the quality.
