Some PMA filings manage to scrape by at U.S. FDA advisory hearings, but the application for the Visability device by Refocus Group Inc. was not one of those. The panel voted 15-1 that the benefits of the device for presbyopia did not outweigh the risks, leaving the sponsor with a fundamental question about the viability of a technology that has been under development for more than 20 years. Read More
Novocure Ltd. has scored another win, this time gaining the CE mark for the NovoTTF-100L system. As a result, Novocure plans to commercialize the device as a first-line treatment in combination with pemetrexed and platinum-based chemotherapy for unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM). Read More
Phagenesis Ltd. reported real-world data showing its Phagenyx system provides significant benefits in the treatment of patients with dysphagia, or difficulty swallowing, due to a variety of causes. Read More
TORONTO – Biomaterials med-tech company 3D Biofibr Inc. has raised CA$550,000 (US$423,500) seed funding to develop, commercialize and scale up a biofilm platform that mimics the spinning behavior of the common spider. Read More
Researchers at the Feinstein Institutes for Medical Research, the research arm of New York-based Northwell Health, illuminated the precise pathway from the brainstem to the spleen that controls inflammation in a study published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS). Essentially, the work demonstrates how scientists could use the vagus nerve to hack the immune system, enabling them to turn down the excessive response that underlies autoimmune disease without the use of biologics or immunosuppressive drugs. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warning letter to company promoting test kits. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hearthero, Novocure. Read More
Keeping you up to date on recent developments in orthopedics, including: Rapid recovery protocol can lead to increased range of motion after TKA; Study compares racial disparities in unilateral vs. bilateral knee replacement surgery; Botox for TMJ disorders may not lead to bone loss in the short term. Read More
