Apollo Endosurgery nabbed an FDA approval for its Orbera Intragastric Balloon in August--which was the third obesity device approved by the agency this year. But Apollo isn't relinquishing its grip on long-standing obesity device Lap-Band, which has faced critiques both on safety and efficacy.
The three manufacturers that market duodenoscopes in the U.S. have all been required by the FDA to submit postmarket surveillance plans to the agency within 30 days. This comes after all three received warning letters from the agency in August and an FDA committee panel took up the same issue in May.
Virtual reality-based therapies are gaining popularity to treat phobias. In addition the U.S. Department of Veterans Affairs is deploying the technology to help veterans overcome post-traumatic stress disorder.
University of Cambridge researchers found that in a pair of similar studies, one in children and adolescents and the other in adults, that an artificial pancreas works better to control blood glucose levels in Type 1 diabetics than self-administration of insulin based on continuous glucose monitor (CGM) data.
The National Institutes of Health called an early halt for an enormous, 9,300+ person trial examining the role of blood pressure intervention due to significant preliminary results. The U.S. agency found that maintaining systolic blood pressure at a lower level than current recommendations reduces rates of heart disease and the risk of death.
Startup Delphinus Medical Technologies has raised $39.5 million to support a pivotal trial of its ultrasound breast cancer system, SoftVue. The system enables the imaging of the entire breast including the chest wall and is expected to be more effective at identifying tumors in dense breasts--without creating a high false positive rate.
Hand-held vital sign monitor Scanadu has made a big splash with its Indiegogo crowdfunding campaign that was followed up by being selected as a finalist in the $10 million Qualcomm Tricorder Xprize competition last year. Now it's working to legitimize its Scanadu Scout wireless vital sign monitor in a massive trial of more than 4,000 people conducted by Scripps Translational Science Institute.
Abbott announced that its bioresorbable scaffold performed similarly to its traditional drug-eluting stent in a clinical trial for Japanese approval. The device is the market leader by far, and is already available in more than 90 countries, though not the U.S.
Germany's coramaze technologies announced that it is receiving €4.5 million ($5.05 million) in a Series A round led by Israel's Elron Electronic Industries, making it the latest player in the burgeoning field of transcatheter mitral valve devices.
St. Jude Medical's leadless pacemaker fared well in its investigational U.S. trial, as the company seeks to secure FDA approval for the device and overcome a safety scare that marred its European launch.