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  • Medtronic Receives Regulatory Approval for Surgical Navigation Device

    According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system.  The system will assist surgeons performing procedures within the ear, nose, and throat (ENT) anatomy. Medtronic explains that the StealthStation™ ENT works by generating an electromagnetic field within t ...
  • Netherlands Adopts US FDA-based UDI System for Medical Devices

    A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and Drug Administration’s Unique Device Identification (UDI) system. According to the post, Dutch hospitals agreed to use UDI codes exclusively for identification and traceab ...
  • FDA Approves First-Ever Mobile App for Addiction Treatment

    The FDA recently approved the marketing of the first-ever prescription digital therapeutic to be used in the treatment of substance use disorder (SUD). The reSET® mobile app, developed by Pear Therapeutics, is approved to assist individuals undergoing outpatient therapy for alcohol, cocaine, marijuana, and stimulant addictions.  The application is not intended for use in treating opioid depen ...
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