The US International Trade Commission has issued a final ruling that Apple infringed on AliveCor Inc.’s patented electrocardiogram technology and banning the offending Apple Watches (series 4, 5, 6, 7 and 8) from being imported into the country.
All Eyes On US Patent And Trademark Board As ITC Approves Apple Watch Import Ban
An import ban on Apple Watches has been put on hold as the US Patent and Trial and Appeal Board (PTAB) reviews AliveCor’s patent appeal.
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Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.
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A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.
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A planned merger between medical device coating manufacturers Surmodics and Biocoat is facing an antitrust lawsuit from the US Federal Trade Commission. The FTC believes the move would create an illegal monopoly.
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An attorney representing the ACLA in its lawsuit to stop the US FDA’s final rule on LDTs emerged from a lengthy hearing on the case feeling ‘cautiously optimistic’ and said a decision could come before May.
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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.