Some top hearing aid manufacturers have tried to deter the US Food and Drug Administration from releasing a final rule that would allow hearing aids to be sold over the counter, said Sens. Elizabeth Warren, D-MA, and Chuck Grassley, R-IA.
Eargo CEO ‘Enthusiastic’ About Pending OTC Hearing Aid Sales
The CEO of direct-to-consumer hearing aid manufacturer Eargo says an OTC category for hearing aids would improve the quality of life for many Americans with hearing loss.
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A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.
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Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
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AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.