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  • FDA Updates Cybersecurity Guidance

    By Matthew Ruth (May 30, 2023) Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA.  Congress made this change by adding Section 524B to the Federal Food, Drug, and Cosmetic Act (FD&C Act) at the end of 2022, addressing concerns over the cybersecurity of medical devices. Risks from cybersecurity incidents involving medical d ...
  • Brain Computer Interface Developer Announces $33M Series A, Granted FDA “Breakthrough” Designation

    Brain computer interface developer Paradromics on May 18, 2023, announced a $33 million Series A funding round as well as a "Breakthrough Device Designation" from the FDA. The funding is reportedly for the company's first-in-human clinical trial of the brain computer interface technology, named the Connexus® Direct Data Interface (DDI).  The company states that "[t]he first application of the ...
  • DuPont to Acquire Spectrum Plastics Group

    DuPont announced on May 2, 2023 its acquisition of Spectrum Plastics Group (“Spectrum”), a specialty plastics manufacturer, from the private equity firm AEA Investors for $1.75 billion. Headquartered in Atlanta, GA, Spectrum was formed in 2017 via a merger of Pexco LLC and PPC Industries (including its Kelpac Medical subsidiary) as a portfolio company of the private equity firm Kohlberg &am ...
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