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.
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).
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warning letter to company promoting test kits.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hearthero, Novocure.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiocrine, Bioxcel, Gyroscope, Inventiva, Sebela, Sorrento, Surface.
The U.S. FDA final guidance for microneedling devices is a product-specific guidance, but it raises questions about the agency’s perspective on how a manufacturer’s intended use is inferred. Despite concerns voiced by industry, the microneedling devices final guidance retains a feature of the draft that allows the agency to infer intended use from the manufacturer’s “expressions,” a provision that raises yet again the long-standing commercial speech problem.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC updates vaccine guidance; Russia launches doctor-driven shortage reporting service.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocartis, Icotec, Materialise, Medcad.
Now that the FDA has granted emergency use authorization to Eli Lilly and Co.’s bamlanivimab, the company plans to manufacture up to 1 million doses of the therapy by year-end with worldwide distribution to mild to moderate COVID-19 patients ages 12 and older in early 2021.
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