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  • Apple, Fitbit Join Pilot Program to Quicken FDA Regulatory Review

    On September 26, 2017, the FDA announced that it has chosen nine tech companies to participate in a pilot program (FDA Pre-Cert) to help tech companies bypass some regulations that have hindered health software and products release, Bloomberg reports. According to the Bloomberg article, this program operates as a “fast track” for these technology companies, which amongst others include Apple, ...
  • 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 ...
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