An Investigational Device Exemption (IDE) approval is necessary before conducting FDA sanctioned medical device clinical trials. Companies often (around 200 times per year) utilize an informal pre-IDE ...

Microbot Medical Inc. MBOT recently announced that it has filed an Investigation Device Exemption (IDE) application with the FDA. The FDA's clearance of the IDE application would enable the business ...

In what could prove to be a transformational development in cancer treatment, Vivos (OTCQB: RDGL), the maker of the Radiogel™ Precision Radionuclide Therapy, submitted an application to the U.S. Food ...

An Investigational Device Exemption (IDE) allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval ...

The Arduino development team have today announced the availability of the Arduino Pro IDE v0.0.4-alpha making it available for windows, Mac OS and Linux. The source code is now available to download ...

Kennewick, WA, July 14, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), a pioneer in Precision Radionuclide Therapy TM (PRnT) solutions, today announced the submission of its Investigational Device ...

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PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has ...

To establish feasibility before finalizing a device's design To capture data relating to safety and efficacy on near-final or final device design to plan for a critical study To facilitate the study ...