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Medical Devices › Breakthrough Therapy Designation

Knobbe Martens

Alpha Tau Receives FDA Breakthrough Device Designation for Alpha DaRT Treatment of GBM

Knobbe Martens on

Alpha Tau Medical Ltd. (“Alpha Tau”) is a medical technology start-up focused on the research, development, and commercialization of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) treatment for solid cancerous...more

McDermott Will & Emery

FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers

McDermott Will & Emery on

As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Draft Guidance on Breakthrough Devices Program

Wilson Sonsini Goodrich & Rosati on

The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more

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