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In a trial, the device demonstrated 89 percent accuracy compared with the standard of care, an invasive heart catheter to measure pulmonary capillary wedge pressure. Read More
LumiThera has announced positive 13-month findings from its LIGHTSITE III clinical study in which patients with dry age-related macular degeneration (AMD) were treated with the company’s Valeda light delivery system. Read More
The FDA has reclassified ophthalmic drugs packaged with eye cups, eye droppers or other dispensers as “drug-led combination products” rather than just drugs, the agency said in a final guidance. Read More
The new company will have behind it almost 100 years of experience in insulin delivery, and approximately 2,000 employees in various countries. Read More
San Diego, Calif.-based Biological Dynamics’ Verita blood test detected 96 percent of stage 1 pancreatic cancers and three-quarters of stage 1 ovarian cancers in a pilot study, the company said. Read More
Nyxoah’s Genio nerve simulation system significantly reduced the severity of sleep apnea, according to the latest, nonpeer-reviewed results from a human study. Read More